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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PVP SMALL 4.3CM X 4.3CM MESH, SURGICAL, POLYMERIC

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ETHICON INC. PVP SMALL 4.3CM X 4.3CM MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number PVPS
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adhesion(s) (1695); Diarrhea (1811); Inflammation (1932); Nausea (1970); Pain (1994); Chills (2191); Weight Changes (2607); Decreased Appetite (4569)
Event Type  Injury  
Manufacturer Narrative

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) 2010 and mesh was implanted. It was reported that the patient underwent revision surgery on (b)(6) 2010 and mesh was implanted during which the surgeon noted the mesh had rolled up on itself superiorly, resulting in recurrent. He lysed omental adhesions. It was reported that the patient experienced severe pain, nausea, diarrhea, chills, inflammation, loss of appetite and extreme weight loss. Other procedure is captured under separate file. No additional information was provided.

 
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Brand NamePVP SMALL 4.3CM X 4.3CM
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
1000 route 202
raritan NJ 08869
Manufacturer (Section G)
ETHICON INC.-GMBH
p.o. box 1409
norderstedt D2284 1
GM D22841
Manufacturer Contact
elba bello
1000 route 202
raritan, NJ 08869
MDR Report Key12165255
MDR Text Key261439460
Report Number2210968-2021-06312
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 07/13/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/14/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberPVPS
Device Catalogue NumberPVPS
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/12/2021
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: 07/14/2021 Patient Sequence Number: 1
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