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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 Fever (1858); Nausea (1970); Scarring (2061)
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) 2012 and mesh was implanted.It was reported that the patient underwent removal surgery on an unknown date.It was reported that the patient experienced severe pain and chronic pain/discomfort, nausea, fever, chills, inflammation, adhesions and severe scarring.No additional information was provided.
 
Manufacturer Narrative
Date sent to the fda: 12/2/2020.
 
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Brand Name
PVP SMALL 4.3CM X 4.3CM
Type of Device
MESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876
MDR Report Key10874352
MDR Text Key217298819
Report Number2210968-2020-09155
Device Sequence Number1
Product Code FTL
UDI-Device Identifier10705031132412
UDI-Public10705031132412
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,Followup
Report Date 11/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
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
Initial Date Manufacturer Received 11/17/2020
Initial Date FDA Received11/20/2020
Supplement Dates Manufacturer Received11/25/2020
Supplement Dates FDA Received12/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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