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

Model Number 810081

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

Patient Problems Autoimmune Disorder (1732); Incontinence (1928); Itching Sensation (1943); Nerve Damage (1979); Pain (1994); Rash (2033); Urinary Tract Infection (2120); Ambulation Difficulties (2544)

Event Date 06/05/2011

Event Type  Injury  

Event Description

It was reported that a patient underwent a sling procedure on (b)(6) 2011 and the mesh was implanted.It was reported that the patient experienced painful sexual intercourse, pain if sitting, standing or lying down for a period of time, autoimmune symptoms (graves disease diagnosis that has gone into remission without treatment, psoriasis), rashes, pelvic pain, itchy groin, urinary issues, vaginal tightness, recurrent sui, leukocytes in urine and occasional utis.It was also reported that the patient feels there was always a uti, nerve damage (though undiagnosed), and a limp for no apparent reason.Additional information was requested.

Manufacturer Narrative

(b)(4).Lot 1123508609 is an invalid lot number, therefore no dhr review can be performed.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.If in your possession, may we have a copy of your operative report? does ethicon have your permission to contact your surgeon, in the event ethicon would like to contact your surgeon for more clinical information to be used for a product quality complaint investigation? if so, please provide your surgeon¿s name, contact information and sign release of medical information form attached.

• Brand Name: GYNECARE TVT OBTURATOR
• 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: 12968076
• MDR Text Key: 286748268
• Report Number: 2210968-2021-12448
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 10705031000346
• UDI-Public: 10705031000346
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K033568
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 810081
• Device Catalogue Number: 810081
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female