MAUDE Adverse Event Report: ETHICON INC. TVT DEVICE WITH PROLENE TAPE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Catalog Number 810041

Device Problem Migration (4003)

Patient Problems Erosion (1750); Incontinence (1928); Itching Sensation (1943); Pain (1994); Blood Loss (2597); Not Applicable (3189)

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) 2000 and mesh was 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.No additional information was provided.

Manufacturer Narrative

Date sent to fda: 9/8/2020.H6 patient code: 1930.Additional information: additional b5 narrative: it was reported that the patient experienced bleeding, infection, stress urinary incontinence, vaginal itching following the procedure.It was reported that the patient underwent removal surgery on (b)(6) 2011.

• Brand Name: TVT DEVICE WITH PROLENE TAPE
• 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: 10355696
• MDR Text Key: 201351766
• Report Number: 2210968-2020-05708
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• PMA/PMN Number: K012628
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 07/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 810041
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention