MAUDE Adverse Event Report: ETHICON INC. GYNECARE PROLIFT+M ANTERIOR; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Catalog Number PFRA02

Device Problem Migration (4003)

Patient Problems Erosion (1750); Fistula (1862); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Pain (1994); Urinary Tract Infection (2120); Discomfort (2330); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

It was reported by an attorney that the patient underwent a gynecological surgical procedure on (b)(6) 2011 and two mesh products were implanted.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 has undergone multiple surgeries and revisionary procedures.It was reported that following insertion the patient experienced infection, urinary problems, bowel problems, recurrence, bleeding and dyspareunia.It was reported that the patient underwent mesh removal on (b)(6) 2015 due to discomfort, urinary tract infection and fistula.It was reported that the patient underwent transvaginal excision of mesh on (b)(6) 2015 and (b)(6) 2016.No additional information was provided.

Manufacturer Narrative

This emdr represents supplemental report #2210968-2016-31837 for previously submitted mdr number 2210968-2016-31580, subject of a litigation complaint summary exemption no. e2013037.  (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.

• Brand Name: GYNECARE PROLIFT+M ANTERIOR
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12646792
• MDR Text Key: 281398024
• Report Number: 2210968-2021-09796
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• PMA/PMN Number: K071512
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 10/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2013
• Device Catalogue Number: PFRA02
• Device Lot Number: 3492863
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR