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

Model Number 810081

Device Problem Migration (4003)

Patient Problems Erosion (1750); Micturition Urgency (1871); Incontinence (1928); Pain (1994); Scar Tissue (2060); Urinary Frequency (2275); Urethral Stenosis/Stricture (4501); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

It was reported by an attorney that the patient underwent a gynecological surgical procedure on (b)(6) 2013 and mesh was implanted.It was reported that the patient experienced pain, erosion of her internal bodily tissue and other injuries following the procedure.It was reported that following insertion the patient experienced dyspareunia, urethral stricture, nocturia, urge incontinence, urgency, urinary frequency, and urethral scarring.It was reported that the patient underwent removal surgery on (b)(6) 2015.No additional information was provided.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 09/27/2022.(b)(4).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.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.This event was previously submitted under ethicon mdr summary reporting exemption e2013037.Initial psr reporting period: february 1, 2017 through march 31, 2017 psr submission number: 2210968-2017-00652.Psr report identifier: (b)(4).

• 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 ; 9083863534
• MDR Report Key: 15499701
• MDR Text Key: 300764226
• Report Number: 2210968-2022-07992
• 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: 09/27/2022

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: 07/31/2014
• Device Model Number: 810081
• Device Catalogue Number: 810081
• Device Lot Number: 3720090
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/23/2022
• Initial Date FDA Received: 09/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Sex: Female