Catalog Number 320-42-00 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Information (3190)
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Event Date 10/04/2016 |
Event Type
Injury
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Manufacturer Narrative
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The contribution of the devices to the experience reported could not be determined as the devices were not returned for evaluation.Additionally, the device specific information was not provided, precluding a review of the device history record.
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Event Description
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Revision due to subscap failure.The case report form indicates the event is unlikely related to the devices and definitely related to procedure.This event report was received through clinical data collection activities.
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Manufacturer Narrative
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The contribution of the devices to the experience reported could not be determined as the devices were not returned for evaluation.Additionally, the device specific information was not provided, precluding a review of the device history record.
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Event Description
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Revision due to subscap failure.The case report form indicates the event is unlikely related to the devices and definitely related to procedure.This event report was received through clinical data collection activities.
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Search Alerts/Recalls
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