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

Catalog Number PFRT02

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)

Patient Problems Micturition Urgency (1871); Incontinence (1928); Pain (1994); Injury (2348)

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 on (b)(6) 2010 and mesh was implanted.It was reported that the patient experienced undisclosed adverse event.No additional information was provided.

Manufacturer Narrative

Date sent to fda: 10/23/2020.Additional h6 patient codes: 1750,1930,3191-fibroids,3189-surgical intervention.Additional b5 narrative: it was reported that the patient experienced pelvic pain, incontinence, urge to urinate and fibroids on uterus.It was reported that the patient underwent partial revision surgery on (b)(6) 2019 due to erosion, urinary incontinence, pelvic pain and bladder infection.

Manufacturer Narrative

Date sent to fda: 10/29/2020.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

• Brand Name: GYNECARE PROLIFT+M TOTAL
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9902999
• MDR Text Key: 186519059
• Report Number: 2210968-2020-02473
• 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
• Source Type: other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/30/2020

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: 01/31/2012
• Device Catalogue Number: PFRT02
• Device Lot Number: 3270158
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/27/2020
• Initial Date FDA Received: 03/31/2020
• Supplement Dates Manufacturer Received: 10/22/2020; 10/28/2020
• Supplement Dates FDA Received: 10/23/2020; 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention