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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PROLENE*SOFT POLYPROPYLENE MESH; MESH, SURGICAL, POLYMERIC
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ETHICON INC. PROLENE*SOFT POLYPROPYLENE MESH; MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number SPMII
Medical Device Problem Code Migration (4003)
Health Effect - Clinical Codes Erosion (1750); Pain (1994); Not Applicable (3189)
Type of Reportable Event Serious Injury
Additional 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.Report submission exceeding 30 days due to fdas exemption transitioning period.
 
Event or Problem Description
It was reported by an attorney that the patient underwent a gynecological procedure on (b)(6) 2016 and mesh was implanted due to pelvic organ prolapse.It was reported that she experienced pain, erosion of her internal bodily tissue and other injuries following the procedure.It was reported that the patient underwent a procedure to remove the mesh in (b)(6) of 2017.No additional information was provided.
 
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Common Device Name
MESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
MDR Report Key8656434
Report Number2210968-2019-81806
Device Sequence Number11324521
Product Code FTL
UDI-Device Identifier10705031050471
UDI-Public10705031050471
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K962530
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 03/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Catalogue NumberSPMII
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 03/11/2019
Initial Report FDA Received Date05/30/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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