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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 Diarrhea (1811); Nausea (1970); Chills (2191)
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.

 
Event Description

It was reported by an attorney 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) 2018 during which the surgeon noted mesh severely adhered to the bowel that a portion of the bowel had become non-viable, necessitating a bowel resection. It was reported that the patient experienced severe pain, nausea, diarrhea, chills, inflammation, loss of appetite, and extreme weight loss. The patient had a previous mesh implanted on (b)(6) 2012 which is captured in a 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
MDR Report Key11007756
MDR Text Key221730701
Report Number2210968-2020-09911
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 12/09/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/15/2020
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 Received12/07/2020
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

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