MAUDE Adverse Event Report: ETHICON INC. TVT EXACT RETROPUBIC SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Model Number TVTRL

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

Patient Problems Erosion (1750); Incontinence (1928); Unspecified Infection (1930); Pain (1994); Scarring (2061); Injury (2348); Not Applicable (3189)

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 attorney that the patient underwent a gynecological surgical procedure on (b)(6) 2012 and mesh was implanted.It was reported that the patient experienced undisclosed adverse event.It was reported that the patient underwent a previous gynecological surgical procedure on (b)(6) 2005 and mesh was implanted.Other procedure is captured on a separate file.No additional information was provided.

Manufacturer Narrative

Date sent to fda: 07/03/2020.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

Manufacturer Narrative

Date sent to fda: 07/02/2020.H6 patient codes: 3189 - surgical intervention.Additional information: b2.Additional b5 narrative: it was reported that the patient 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.

Manufacturer Narrative

Date sent to fda: 09/04/2020.Additional information: additional b5 narrative: it was reported that following insertion the patient experienced infection, scarring and incontinence.It was reported that the patient underwent mesh revision on (b)(6) 2019.

• Brand Name: TVT EXACT RETROPUBIC SYSTEM
• 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: 10211619
• MDR Text Key: 197285855
• Report Number: 2210968-2020-04929
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 10705031062375
• UDI-Public: 10705031062375
• Combination Product (y/n): N
• PMA/PMN Number: K132054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/29/2020

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: 06/30/2012
• Device Model Number: TVTRL
• Device Catalogue Number: TVTRL
• Device Lot Number: 3545717
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/26/2020
• Initial Date FDA Received: 06/30/2020
• Supplement Dates Manufacturer Received: 06/26/2020; 07/03/2020; 09/03/2020
• Supplement Dates FDA Received: 07/02/2020; 07/03/2020; 09/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention