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

Catalog Number 810041

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

Patient Problems Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Ambulation Difficulties (2544)

Event Date 10/01/2005

Event Type  Injury  

Manufacturer Narrative

(b)(4).Lot 1080742 was unavailable for review therefore an assessment memo was available for product code 810041.To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.

Event Description

It was reported that the patient underwent a gynecological procedure on (b)(6) 2003 and the mesh was implanted.Post-op, the patient experienced symptoms of urinary tract infection, difficulty urinating, pain of pelvic area, hips and legs, difficulty walking and climbing stairs.No further information is available.

• 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
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20; neuchatel ; SZ
• Manufacturer Contact: kara ditty-bovard ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 6107428552
• MDR Report Key: 9271991
• MDR Text Key: 164876068
• Report Number: 2210968-2019-89442
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/07/2019

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: 03/31/2008
• Device Catalogue Number: 810041
• Device Lot Number: 1080742
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/07/2019
• Initial Date FDA Received: 11/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2003
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention