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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
Catalog Number PVPM
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); 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.
 
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 (b)(6) 2015 during which the surgeon noted a large hernia sac almost 6x6 cm which appeared to have old mesh in it. It was dissected out. After excising the previous sutures, the retroperitoneal tissues were dissected out. It was reported that the patient experienced severe pain, burning and mrsa. No additional information is provided.
 
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Brand NamePVP MEDIUM 6.4CM X 6.4CM
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876
Manufacturer (Section G)
ETHICON INC.-GMBH
p.o. box 1409
norderstedt GA D2284 1
GM D22841
Manufacturer Contact
elba bello
p.o. box 151, route 22 west
somerville, NJ 08876
9082183429
MDR Report Key10402712
MDR Text Key202862475
Report Number2210968-2020-06084
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,Followup,Followup,Followup
Report Date 08/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/13/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/31/2012
Device Catalogue NumberPVPM
Device Lot NumberEA8JHXZ0
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/19/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/19/2012
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: 08/13/2020 Patient Sequence Number: 1
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