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

Catalog Number GPSL34

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Injury (2348); 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.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.(b)(4) submitted for adverse event which occurred on (b)(6) 2017.(b)(4) submitted for adverse event which occurred on (b)(6) 2020.

Event Description

It was reported by an attorney that the patient underwent a gynecological surgical procedure on (b)(6) 2010 and meshx2 were implanted.It was reported that the patient underwent partial revision surgery on (b)(6) 2017 due to the mesh being eroded and exposed causing pain and dyspareunia.It was reported that the patient underwent partial revision surgery on (b)(6) 2020.No additional information was provided.

• Brand Name: GYNECARE GYNEMESH PS
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km. 8.3; san lorenzo PR 00754 ; * 00754
• Manufacturer Contact: elba bello ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 9082183429
• MDR Report Key: 10261476
• MDR Text Key: 198439728
• Report Number: 2210968-2020-05212
• Device Sequence Number: 1
• Product Code: OTO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K013718
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/08/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2014
• Device Catalogue Number: GPSL34
• Device Lot Number: BKP211
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/06/2020
• Initial Date FDA Received: 07/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR