Device Problem
Sticking (1597)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
Injury
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Manufacturer Narrative
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Based on the available information, this event is deemed to be a serious injury.No patient harm was reported.It was further reported that the product is "most likely (b)(4)." this information could not be confirmed at the time of this report.Additional patient/event information has been requested but no information has been received to date.Should additional information become available, a follow-up report will be submitted.(b)(4).
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Event Description
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Complainant reported that the "dressing stuck to the incision site during dressing removal." complainant stated that dermabond was used at the incision site and the dressing was applied twenty-four (24) hours later.
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Manufacturer Narrative
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Additional information: no lot number or product evaluation sample was available for investigation.Therefore, a detailed investigation or batch review cannot be conducted.This complaint evaluation will be closed and will be monitored through our post market product monitoring review process.No further actions are needed.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.(b)(4).
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Search Alerts/Recalls
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