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 Fatigue (1849); Pain (1994); Ambulation Difficulties (2544)

Event Date 11/16/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria for lot 3920005 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 Description

It was reported that a patient underwent a sling procedure on (b)(6) 2016 and the mesh was implanted.It was reported that the patient experienced permanent hip pain, side difficulties, difficulties during sexual intercourse, difficulty in sitting for a long time because of pain, the feel of movement in the stomach, stoppage of work for fatigue, pain in shoulder, as well as hip, right side, and right foot.It was also reported that the patient experienced pain in the vagina, and constant heat as if the patient was wearing panties too tight all the time.It was reported that the pain was constant.It was also reported that the patient was limited to short walking.

• 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: 12215102
• MDR Text Key: 265645242
• Report Number: 2210968-2021-06621
• 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: consumer,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

• Date FDA Received: 07/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Model Number: 810041B
• Device Catalogue Number: 810041B
• Device Lot Number: 3920005
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1