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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
Catalog Number PVPS
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Inflammation (1932); Pain (1994); Burning Sensation (2146)
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. In addition, a review of the manufacturing records was performed and indicates that there were no quality concerns associated with the manufacturing process.
 
Event Description
It was reported by an attorney that the patient underwent umbilical hernia repair surgery on (b)(6) 2011 and mesh was implanted. It was reported that the patient underwent removal surgery on (b)(6) 2013 during which the surgeon noted ¿a piece of mesh removed with attached peritoneum. The omentum is freed up from attachments to the edges of the fascial defect and pushed back into the abdominal cavity. ¿ it was reported that the patient experienced severe pain, inflammation and burning sensations. No additional information is provided.
 
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Brand NamePVP SMALL 4.3CM X 4.3CM
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
Manufacturer (Section G)
ETHICON INC.-GMBH
p.o. box 1409
norderstedt D2284 1
GM D22841
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key8932252
MDR Text Key155646569
Report Number2210968-2019-86087
Device Sequence Number1
Product Code FTL
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
Report Date 08/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/26/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/30/2011
Device Catalogue NumberPVPS
Device Lot NumberCP8GGMZ0
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/22/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/01/2010
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: 08/26/2019 Patient Sequence Number: 1
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