MAUDE Adverse Event Report: ETHICON INC. TVT SECUR 1UP; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Catalog Number TVTS1

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Abdominal Pain (1685); Incontinence (1928); Pain (1994); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123)

Event Type  Injury  

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.

Event Description

It was reported by an attorney that the patient underwent a gynecological surgical procedure on (b)(6) 2008 for mesh vaginal repair and suspension, cystoscopy and mesh was implanted, due to recurrent cystocele and stress urinary incontinence.It was reported that the patient experienced abdominal pain, vaginal discharge, dyspareunia, and urinary tract infections.It was reported that the patient underwent surgery for resection of vaginal mesh from vault and anterior vagina, resection of vaginal wall mesh with vaginal wall repair, suprapubic cystotomy with catheter, and removal of bladder mesh with stones and partial cystectomy.No additional information was provided.

Manufacturer Narrative

Date sent to the fda: 10/25/2022.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

• Brand Name: TVT SECUR 1UP
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; neuchatel ; SZ
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15578574
• MDR Text Key: 301495020
• Report Number: 2210968-2022-08285
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K052401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2010
• Device Catalogue Number: TVTS1
• Device Lot Number: 3135704
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2008
• 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