MAUDE Adverse Event Report: ETHICON INC. GYNEMESH PS (PROLENE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Catalog Number	GPSL
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Erosion (1750); Hypersensitivity/Allergic reaction (1907); Nerve Damage (1979); Pain (1994); Urinary Tract Infection (2120); Not Applicable (3189)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported that the patient underwent a gynecological procedure on an unknown date and mesh was implanted.The mesh eroded in the vagina on three occasions which required additional surgery.The patient also experienced chronic pain, sensitivity to plasters and iv covers, pudendal nerve damage, increased number of urinary tract infections, dyspareunia and pain when walking.Additional information will be requested.
Additional Manufacturer Narrative
In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

• Brand Name: GYNEMESH PS (PROLENE
• Common Device Name: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7337802
• Report Number: 2210968-2018-71430
• Device Sequence Number: 1157297
• Product Code: OTO
• UDI-Device Identifier: 20705031037738
• UDI-Public: 20705031037738
• Combination Product (Y/N): N
• PMA/510(K) Number: K013718
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2018

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 Expiration Date: 01/31/2012
• Device Catalogue Number: GPSL
• Device Lot Number: ZGB443
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2018
• Initial Date Received by Manufacturer: 02/16/2018
• Supplement Date Received by Manufacturer: 02/16/2018
• Initial Report FDA Received Date: 03/14/2018
• Supplement Report FDA Received Date: 03/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention