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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PVP MEDIUM 6.4CM X 6.4CM MESH, SURGICAL, POLYMERIC

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ETHICON INC. PVP MEDIUM 6.4CM X 6.4CM MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number PVPM
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fistula (1862); Hypoesthesia (2352); Obstruction/Occlusion (2422)
Event Type  Injury  
Manufacturer Narrative

(b)(4). To date, the device has not been returned. If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form. (b)(4) submitted for adverse event which occurred on (b)(6) 2013. (b)(4) represents the adverse event which occurred on (b)(6) 2017.

 
Event Description

It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2011 and mesh was implanted. It was reported that the patient underwent hernia repair surgery on (b)(6) 2013 and mesh was implanted. It was reported that the patient underwent removal surgery on (b)(6) 2017 during which the surgeon noted multiple loops of bowel that were matted to this old mesh. The old mesh was removed, felt that it would cause some type of fistula or bowel obstruction in the future. It was reported that the patient experienced severe pain, nausea, numbness and shortness of breath. It was reported that the patient previously underwent hernia repair surgery on (b)(6) 2009 and mesh was implanted. Other procedures are captured in separate file. No additional information was provided.

 
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Brand NamePVP MEDIUM 6.4CM X 6.4CM
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876
Manufacturer (Section G)
ETHICON INC.-GMBH
p.o. box 1409
norderstedt D2284 1
GM D22841
Manufacturer Contact
elba bello
p.o. box 151, route 22 west
somerville, NJ 08876
9082183429
MDR Report Key10743520
MDR Text Key214344921
Report Number2210968-2020-08242
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK061533
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Initial
Report Date 10/21/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/27/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberPVPM
Device Catalogue NumberPVPM
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/20/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 10/27/2020 Patient Sequence Number: 1
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