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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 Fatigue (1849); Inflammation (1932); Nausea (1970); Pain (1994); Hernia (2240); Decreased Appetite (4569)
Event Type  Injury  
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 recurrent hernia repair surgery on (b)(6) 2015. It was reported that the patient underwent revision surgery on (b)(6) 2016 during which the surgeon noted that the previously placed mesh had hardened and was tacked only on one side. He was able to envelope the mesh so the hard disc was no longer palpable. It was reported that the patient experienced severe pain, nausea, inflammation, loss of appetite, weakness, stress and anxiety. No additional information was provided.
 
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. Mwr-(b)(4) submitted for adverse event which occurred on (b)(6) 2015. Mwr-(b)(4) submitted for adverse event which occurred on (b)(6) 2016.
 
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Brand NamePVP MEDIUM 6.4CM X 6.4CM
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
1000 route 202
raritan NJ 08869
MDR Report Key12637410
MDR Text Key282125016
Report Number2210968-2021-09720
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K061533
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial
Report Date 10/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberPVPM
Device Catalogue NumberPVPM
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/13/2021
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 10/14/2021 Patient Sequence Number: 1
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