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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.
 
Manufacturer Narrative
Date sent to fda: 06/29/2020.
 
Manufacturer Narrative
Date sent to fda: 07/01/2020.Additional information: a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
 
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Brand Name
PROLENE MESH 15X15CM
Type of Device
MESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876
MDR Report Key10195759
MDR Text Key197156979
Report Number2210968-2020-04792
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K962530
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Type of Report Initial,Followup,Followup
Report Date 06/23/2020
1 Device was Involved in the Event
1 Patient was 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
Date Manufacturer Received06/24/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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