Model Number 187955 |
Device Problem
Failure To Adhere Or Bond (1031)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Type
malfunction
|
Manufacturer Narrative
|
Based on the available information, this event is deemed to be a reportable malfunction.No additional patient/ event details have been provided to date.Should additional information become available, a follow-up report will be submitted.
|
|
Event Description
|
End user reports the dressing adhesive does not feel sticky which is resulting in the dressing falling off.He attempted to use the dressing anyway and it fell off in less than 1 (one) day.
|
|
Manufacturer Narrative
|
A batch record review indicates no discrepancies.Process checks and quality checks were performed with acceptable results.No additional action is required and this complaint will be closed.This issue will be monitored through the post market monitoring review process.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.Reported to the fda on september 7, 2016.(b)(4).
|
|
Search Alerts/Recalls
|