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

Model Number 810041B

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

Patient Problems Unspecified Infection (1930); Pain (1994); Urinary Tract Infection (2120); Ambulation Difficulties (2544); Unspecified Tissue Injury (4559)

Event Date 02/10/2012

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).(b)(4) device not returned.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria for lot 2913683 and product code 810041b.No additional information is available.If further details are received at a later date a supplemental medwatch will be sent.Event related to patient with the tvt obturator reported via mw # 2210968-2021-06504.

Event Description

It was reported that a patient underwent an unknown gynecological procedure on an unknown date in 2006 and the mesh was implanted.It was reported that the patient experienced device problems in which there was tearing of a vaginal wall, repeated urinary tract infections, difficulty walking and standing up, pain in the groin and lower abdomen, pain in the inner muscles of the legs especially on the left, and infection in the kidney.It was also reported that the patient had an additional operation.

• Brand Name: GYNECARE TVT DEVICE
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20; neuchatel 2000 ; SZ 2000
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12198269
• MDR Text Key: 262555785
• Report Number: 2210968-2021-06503
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 10705031000322
• UDI-Public: 10705031000322
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K012628
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/23/2021

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: 05/31/2009
• Device Model Number: 810041B
• Device Catalogue Number: 810041B
• Device Lot Number: 2913683
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/23/2021
• Initial Date FDA Received: 07/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2006
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention