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

Model Number 810081

Device Problem Migration (4003)

Patient Problems Abdominal Pain (1685); Erosion (1750); Micturition Urgency (1871); Incontinence (1928); Unspecified Infection (1930); Pain (1994); Scar Tissue (2060); Urinary Retention (2119)

Event Type  Injury  

Event Description

It was reported by an attorney that the patient underwent a gynecological surgical procedure on (b)(6) 2020 and mesh was implanted.It was reported that the patient experienced recurrent infections, pain, and abdominal pain on (b)(6) 2021.It was reported that the patient experienced erosion, recurrence of incontinence, vaginal scarring, urinary urgency, groin pain, pelvic pain, dyspareunia, dysuria, incomplete emptying, and fecal incontinence.No additional information was provided.

Manufacturer Narrative

To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.(b)(4) submitted for adverse event which occurred on (b)(6) 2021.

• 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 ; SZ
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15189056
• MDR Text Key: 297495605
• Report Number: 2210968-2022-06379
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 10705031000346
• UDI-Public: 10705031000346
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033568
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: 810081
• Device Catalogue Number: 810081
• Device Lot Number: 3934985
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female