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

Catalog Number PFRT01

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

Patient Problems Pain (1994); Scarring (2061); No Code Available (3191)

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.

Event Description

It was reported by an attorney that the patient underwent a gynecological surgical procedure on (b)(6) 2007 and mesh was implanted, due to pelvic organ prolapse and mesh was implanted, due to sui.It was reported that the patient experienced pelvic and groin pain, dyspareunia, urinary and bowel problems, vaginal scarring, and loss of mobility.No additional information was provided.

Manufacturer Narrative

Date sent to fda: 05/28/2020.Additional information: d4, h4.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

Manufacturer Narrative

Date sent to the fda: 09/13/2021.

• Brand Name: TOTAL PELVIC FLOOR REPAIR SYST
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08876
• MDR Report Key: 10082329
• MDR Text Key: 191809134
• Report Number: 2210968-2020-04088
• 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,Followup
• Report Date: 05/21/2020

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: 05/31/2010
• Device Catalogue Number: PFRT01
• Device Lot Number: 3048088
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/19/2020
• Initial Date FDA Received: 05/22/2020
• Supplement Dates Manufacturer Received: 05/27/2020; 09/10/2021
• Supplement Dates FDA Received: 05/28/2020; 09/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR