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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PROLENE MESH 15X15CM MESH, SURGICAL, POLYMERIC

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ETHICON INC. PROLENE MESH 15X15CM MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number PMM3
Device Problem Migration (4003)
Patient Problems Erosion (1750); Pain (1994)
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 a gynecological surgical procedure in (b)(6) 2012 and mesh was implanted. It was reported that the patient was previously implanted with mesh on (b)(6) 2010. It was reported that she experienced pain, erosion of her internal bodily tissue and other injuries following the procedure. No additional information was provided.

 
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Brand NamePROLENE MESH 15X15CM
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 00754
Manufacturer Contact
elba bello
p.o. box 151, route 22 west
somerville, NJ 08876
9082183429
MDR Report Key10195759
MDR Text Key197156979
Report Number2210968-2020-04792
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
PMA/PMN NumberK962530
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,OTHER
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/23/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/25/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/31/2017
Device Catalogue NumberPMM3
Device LOT NumberEJB903
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 Received06/24/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/08/2012
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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