MAUDE Adverse Event Report: ETHICON INC. TOTAL PELVIC FLOOR REPAIR SYST; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Catalog Number PFRT01

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

Patient Problems Erosion (1750); Pain (1994); Injury (2348); Blood Loss (2597)

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) 2008 and two meshes were implanted.It was reported that the patient experienced undisclosed adverse event.No additional information was provided.

Manufacturer Narrative

Date sent to the fda: 4/29/2020 additional h6 patient code: 3189 - surgical intervention additional information: a1, a2, a4, b7, d7 additional b5 narrative: it was reported that the patient underwent anterior and posterior mesh removal on (b)(6) 2018 due to pain, bleeding and mesh erosion.

• Brand Name: TOTAL PELVIC FLOOR REPAIR SYST
• 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: 9979050
• MDR Text Key: 191006540
• Report Number: 2210968-2020-03211
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• PMA/PMN Number: K013718
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 04/17/2020

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 Catalogue Number: PFRT01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/16/2020
• Initial Date FDA Received: 04/20/2020
• Supplement Dates Manufacturer Received: 04/28/2020
• Supplement Dates FDA Received: 04/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 68