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| AdverseEventReporting UML Documentation |
AdverseEventReporting
Class DeviceObservation
Contains information describing any medical devices (whether suspect or concommittant) used by the subject near the time of the adverse event occurred.
| Attributes |
| «TS» PointInTime |  dateExplanted |
The date the patient stopped using the product. Medwatch 3500 form question E.7; Medwatch 3500A form question D.7; Medwatch 3500B form question C.7.
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| «TS» PointInTime | dateImplanted |
The date the patient began to use the product. Medwatch 3500 form question E.6; Medwatch 3500A form question D.6; Medwatch 3500B form question C.6.
|
| DeviceInstance | deviceInstance |
Pointer to the Device Instance (and therefore more generic information about the device product) that is suspected to have caused the adverse event, product problem, or product use error.Medwatch 3500A form question D.1 (brand name), D.2 (commond device name), D.2.b (Procom), 5, box 2.
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| DeviceOperator | deviceOperator |
Is this product meant to be used only one time (i.e., single-use), but was reprocessed and/or reused? Medwatch 3500 form question E.8; Medwatch 3500A form question D.8.
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| String | otherUserText |
Was the operator or user of the device neither the patient nor a healthcare professional? If yes, the other user text should be valued. Medwatch 3500 form question E.5; Medwatch 3500A form question D.5; Medwatch 3500B form question C.5.
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| «TS» PointInTime | therapyStartDate |
Medwatch 3500A form question D.11.
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| «TS» PointInTime | therapyStopDate |
Medwatch 3500A form question D.11.
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| Boolean | wasSingleUseReprocessed |
Is this product meant to be used only one time (i.e., single-use), but was reprocessed and/or reused?MedWatch 3500 form question E.8.MedWatch 3500A form question D.8.(note that the MedWatch 3500B and the VAERS-1 forms do not have this element).
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Properties:
| Alias | |
| Classifier Behavior | |
| Is Abstract | false |
| Is Active | false |
| Is Leaf | false |
| Keywords | |
| Name | DeviceObservation |
| Name Expression | |
| Namespace | AdverseEventReporting |
| Owned Template Signature | |
| Owner | AdverseEventReporting |
| Owning Template Parameter | |
| Package | AdverseEventReporting |
| Qualified Name | FHIM::AdverseEventReporting::DeviceObservation |
| Representation | |
| Stereotype | |
| Template Parameter | |
| Visibility | Public |
dateExplanted
Public «TS» PointInTime dateExplanted
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The date the patient stopped using the product. Medwatch 3500 form question E.7; Medwatch 3500A form question D.7; Medwatch 3500B form question C.7.
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Constraints:
-
Properties:
-
| Aggregation | None |
| Alias | |
| Association | |
| Association End | |
| Class | DeviceObservation |
| Datatype | |
| Default | |
| Default Value | |
| Is Composite | false |
| Is Derived | false |
| Is Derived Union | false |
| Is Leaf | false |
| Is Ordered | false |
| Is Read Only | false |
| Is Static | false |
| Is Unique | true |
| Keywords | |
| Lower | 0 |
| Lower Value | (0) |
| Multiplicity | 0..1 |
| Name | dateExplanted |
| Name Expression | |
| Namespace | DeviceObservation |
| Opposite | |
| Owner | DeviceObservation |
| Owning Association | |
| Owning Template Parameter | |
| Qualified Name | FHIM::AdverseEventReporting::DeviceObservation::dateExplanted |
| Stereotype | |
| Template Parameter | |
| Type | «TS» PointInTime |
| Upper | 1 |
| Upper Value | (1) |
| Visibility | Public |
dateImplanted
Public «TS» PointInTime dateImplanted
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The date the patient began to use the product. Medwatch 3500 form question E.6; Medwatch 3500A form question D.6; Medwatch 3500B form question C.6.
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Constraints:
-
Properties:
-
| Aggregation | None |
| Alias | |
| Association | |
| Association End | |
| Class | DeviceObservation |
| Datatype | |
| Default | |
| Default Value | |
| Is Composite | false |
| Is Derived | false |
| Is Derived Union | false |
| Is Leaf | false |
| Is Ordered | false |
| Is Read Only | false |
| Is Static | false |
| Is Unique | true |
| Keywords | |
| Lower | 0 |
| Lower Value | (0) |
| Multiplicity | 0..1 |
| Name | dateImplanted |
| Name Expression | |
| Namespace | DeviceObservation |
| Opposite | |
| Owner | DeviceObservation |
| Owning Association | |
| Owning Template Parameter | |
| Qualified Name | FHIM::AdverseEventReporting::DeviceObservation::dateImplanted |
| Stereotype | |
| Template Parameter | |
| Type | «TS» PointInTime |
| Upper | 1 |
| Upper Value | (1) |
| Visibility | Public |
deviceInstance
Public DeviceInstance deviceInstance
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Pointer to the Device Instance (and therefore more generic information about the device product) that is suspected to have caused the adverse event, product problem, or product use error.Medwatch 3500A form question D.1 (brand name), D.2 (commond device name), D.2.b (Procom), 5, box 2.
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Constraints:
-
Properties:
-
| Aggregation | None |
| Alias | |
| Association | suspectedDevice_deviceInstance |
| Association End | |
| Class | DeviceObservation |
| Datatype | |
| Default | |
| Default Value | |
| Is Composite | false |
| Is Derived | false |
| Is Derived Union | false |
| Is Leaf | false |
| Is Ordered | false |
| Is Read Only | false |
| Is Static | false |
| Is Unique | true |
| Keywords | |
| Lower | 1 |
| Lower Value | (1) |
| Multiplicity | 1 |
| Name | deviceInstance |
| Name Expression | |
| Namespace | DeviceObservation |
| Opposite | |
| Owner | DeviceObservation |
| Owning Association | |
| Owning Template Parameter | |
| Qualified Name | FHIM::AdverseEventReporting::DeviceObservation::deviceInstance |
| Stereotype | |
| Template Parameter | |
| Type | DeviceInstance |
| Upper | 1 |
| Upper Value | (1) |
| Visibility | Public |
deviceOperator
Public DeviceOperator deviceOperator
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Is this product meant to be used only one time (i.e., single-use), but was reprocessed and/or reused? Medwatch 3500 form question E.8; Medwatch 3500A form question D.8.
-
Constraints:
-
Properties:
-
| Aggregation | None |
| Alias | |
| Association | |
| Association End | |
| Class | DeviceObservation |
| Datatype | |
| Default | |
| Default Value | |
| Is Composite | false |
| Is Derived | false |
| Is Derived Union | false |
| Is Leaf | false |
| Is Ordered | false |
| Is Read Only | false |
| Is Static | false |
| Is Unique | true |
| Keywords | |
| Lower | 0 |
| Lower Value | (0) |
| Multiplicity | 0..1 |
| Name | deviceOperator |
| Name Expression | |
| Namespace | DeviceObservation |
| Opposite | |
| Owner | DeviceObservation |
| Owning Association | |
| Owning Template Parameter | |
| Qualified Name | FHIM::AdverseEventReporting::DeviceObservation::deviceOperator |
| Stereotype | |
| Template Parameter | |
| Type | DeviceOperator |
| Upper | 1 |
| Upper Value | (1) |
| Visibility | Public |
otherUserText
Public String otherUserText
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Was the operator or user of the device neither the patient nor a healthcare professional? If yes, the other user text should be valued. Medwatch 3500 form question E.5; Medwatch 3500A form question D.5; Medwatch 3500B form question C.5.
-
Constraints:
-
Properties:
-
| Aggregation | None |
| Alias | |
| Association | |
| Association End | |
| Class | DeviceObservation |
| Datatype | |
| Default | |
| Default Value | |
| Is Composite | false |
| Is Derived | false |
| Is Derived Union | false |
| Is Leaf | false |
| Is Ordered | false |
| Is Read Only | false |
| Is Static | false |
| Is Unique | true |
| Keywords | |
| Lower | 0 |
| Lower Value | (0) |
| Multiplicity | 0..1 |
| Name | otherUserText |
| Name Expression | |
| Namespace | DeviceObservation |
| Opposite | |
| Owner | DeviceObservation |
| Owning Association | |
| Owning Template Parameter | |
| Qualified Name | FHIM::AdverseEventReporting::DeviceObservation::otherUserText |
| Stereotype | |
| Template Parameter | |
| Type | String |
| Upper | 1 |
| Upper Value | (1) |
| Visibility | Public |
therapyStartDate
Public «TS» PointInTime therapyStartDate
-
Medwatch 3500A form question D.11.
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Constraints:
-
Properties:
-
| Aggregation | None |
| Alias | |
| Association | |
| Association End | |
| Class | DeviceObservation |
| Datatype | |
| Default | |
| Default Value | |
| Is Composite | false |
| Is Derived | false |
| Is Derived Union | false |
| Is Leaf | false |
| Is Ordered | false |
| Is Read Only | false |
| Is Static | false |
| Is Unique | true |
| Keywords | |
| Lower | 0 |
| Lower Value | (0) |
| Multiplicity | 0..1 |
| Name | therapyStartDate |
| Name Expression | |
| Namespace | DeviceObservation |
| Opposite | |
| Owner | DeviceObservation |
| Owning Association | |
| Owning Template Parameter | |
| Qualified Name | FHIM::AdverseEventReporting::DeviceObservation::therapyStartDate |
| Stereotype | |
| Template Parameter | |
| Type | «TS» PointInTime |
| Upper | 1 |
| Upper Value | (1) |
| Visibility | Public |
therapyStopDate
Public «TS» PointInTime therapyStopDate
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Medwatch 3500A form question D.11.
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Constraints:
-
Properties:
-
| Aggregation | None |
| Alias | |
| Association | |
| Association End | |
| Class | DeviceObservation |
| Datatype | |
| Default | |
| Default Value | |
| Is Composite | false |
| Is Derived | false |
| Is Derived Union | false |
| Is Leaf | false |
| Is Ordered | false |
| Is Read Only | false |
| Is Static | false |
| Is Unique | true |
| Keywords | |
| Lower | 0 |
| Lower Value | (0) |
| Multiplicity | 0..1 |
| Name | therapyStopDate |
| Name Expression | |
| Namespace | DeviceObservation |
| Opposite | |
| Owner | DeviceObservation |
| Owning Association | |
| Owning Template Parameter | |
| Qualified Name | FHIM::AdverseEventReporting::DeviceObservation::therapyStopDate |
| Stereotype | |
| Template Parameter | |
| Type | «TS» PointInTime |
| Upper | 1 |
| Upper Value | (1) |
| Visibility | Public |
wasSingleUseReprocessed
Public Boolean wasSingleUseReprocessed
-
Is this product meant to be used only one time (i.e., single-use), but was reprocessed and/or reused?MedWatch 3500 form question E.8.MedWatch 3500A form question D.8.(note that the MedWatch 3500B and the VAERS-1 forms do not have this element).
-
Constraints:
-
Properties:
-
| Aggregation | None |
| Alias | |
| Association | |
| Association End | |
| Class | DeviceObservation |
| Datatype | |
| Default | |
| Default Value | |
| Is Composite | false |
| Is Derived | false |
| Is Derived Union | false |
| Is Leaf | false |
| Is Ordered | false |
| Is Read Only | false |
| Is Static | false |
| Is Unique | true |
| Keywords | |
| Lower | 0 |
| Lower Value | (0) |
| Multiplicity | 0..1 |
| Name | wasSingleUseReprocessed |
| Name Expression | |
| Namespace | DeviceObservation |
| Opposite | |
| Owner | DeviceObservation |
| Owning Association | |
| Owning Template Parameter | |
| Qualified Name | FHIM::AdverseEventReporting::DeviceObservation::wasSingleUseReprocessed |
| Stereotype | |
| Template Parameter | |
| Type | Boolean |
| Upper | 1 |
| Upper Value | (1) |
| Visibility | Public |
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| AdverseEventReporting UML Documentation |