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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); Purulent Discharge (1812); Granuloma (1876); Inflammation (1932); Nausea (1970); Pain (1994); Scar Tissue (2060); Chills (2191); Fibrosis (3167); 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) 2016 and mesh was implanted. It was reported that the patient underwent removal surgery on (b)(6) 2017 during which the surgeon noted a granuloma, significant fibrosis and thickening along the abdominal wall where the mesh was located and excised. There was densely adherent mesh, intense inflammatory reaction and a widened scar with 2 to 3 sinuses draining purulent appearing fluid. It was reported that the patient experienced severe pain, nausea, diarrhea, chills, inflammation and loss of appetite. 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 Key14691713
MDR Text Key294059187
Report Number2210968-2022-04563
Device Sequence Number1
Product Code FTL
UDI-Device Identifier10705031132412
UDI-Public10705031132412
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K061533
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/15/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2017
Device Model NumberPVPS
Device Catalogue NumberPVPS
Device Lot NumberJM8DZPB0
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received10/03/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/24/2015
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: 06/15/2022 Patient Sequence Number: 1
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