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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PROLENE MESH 3INX6IN MESH, SURGICAL, POLYMERIC

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ETHICON INC. PROLENE MESH 3INX6IN MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number PMII
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hernia (2240); Not Applicable (3189)
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 removal surgery and recurrent hernia repair surgery on (b)(6) 2009 and mesh was implanted during which the surgeon noted evidence of old mesh. There was a wad of mesh at the internal ring. There was also mesh along the patient¿s inguinal canal and including external oblique. Once the mesh was removed, the vas deferens of the spermatic cord was noted. There was evidence of a weakness in the floor consistent with a direct hernia. It was reported that the patient underwent right inguinal hernia repair surgery on (b)(6) 2017 and mesh was implanted. It was reported that the patient experienced an unknown event. It was reported that the patient previously underwent hernia repair surgery on (b)(6) 2005 and mesh was implanted. Other procedure is captured in separate file. No additional information was provided.

 
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Brand NamePROLENE MESH 3INX6IN
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.-SAN LORENZO PR
982 road 183 km 8.3
san lorenzo PR
Manufacturer Contact
elba bello
p.o. box 151, route 22 west
somerville, NJ 08876
9082183429
MDR Report Key10837143
MDR Text Key216178315
Report Number2210968-2020-09025
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK180829
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/11/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/13/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/31/2014
Device MODEL NumberPMII
Device Catalogue NumberPMII
Device LOT NumberBEE879
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 Received11/23/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/15/2009
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: 11/13/2020 Patient Sequence Number: 1
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