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

Catalog Number 810081

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

Patient Problems Fatigue (1849); Incontinence (1928); Unspecified Infection (1930); Pain (1994); Depression (2361); Ambulation Difficulties (2544)

Event Date 08/18/2012

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 3612220 and product code 810081.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) 2012 and the mesh was implanted.Post-op, the patient experienced pain in groin, lower back and hips, pain in the left and right sacroiliac, right leg drags when walking, difficulty walking for a long time and/or on unstable surfaces.The patient is not able to remain in a sitting position without pain, feeling of pulling in the groin and leg, and no longer able to wear a tampon.For about 4 years, the patient experienced uncontrollable vaginal infection.About 1 1/2 years the patient was without bladder leakage, then leaking is the same or worse than before.The patient also experienced chronic urticaria that has started after the initial surgery.In 2015 the patient had depression and fatigue, gained weight due to pain and was taken antidepressant medication.No further information is available.

• Brand Name: GYNECARE TVT OBTURATOR
• 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: 9264623
• MDR Text Key: 167876423
• Report Number: 2210968-2019-89349
• 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: 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: 03/28/2013
• Device Catalogue Number: 810081
• Device Lot Number: 3612220
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/07/2019
• Initial Date FDA Received: 10/31/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention