MAUDE Adverse Event Report: ETHICON INC. TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Pain (1994); Urinary Tract Infection (2120); Unspecified Tissue Injury (4559)

Event Date 01/01/2016

Event Type  Injury  

Event Description

It was reported that a patient underwent a sling procedure on (b)(6) 2014 and mesh was implanted.Following implantation, pelvic neuropathic pain occurred.At the request of the surgeon who operated because without any solution, he requested an opinion from the gynecological department who cut the strip.Despite this, the pain continued.Charge was taken by the facility pain center and drug treatment was provided (duloxetine and laroxyl).Since then, the patient followed-up with urology for recurrent urinary infections.In 2021, urology intervention was performed to remove bullous lesions on the walls of the bladder.Today, the neuropathic pain continues.The area where the strip passes under the urethra is painful.After a pelvic ultrasound, it turns out that the strip under the urethra is under strong tension.To this day, the patient still has neuropathic pain, hypersensitivity of the bladder and urethra, and painful intercourse.The neuropathic pain is located throughout the pelvic area, but also from time to time in the level of the lower back and sacrum.All these symptoms occurred after the test strip was placed.No further information is available.

Manufacturer Narrative

(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.To date it has been reported that the device will not be returned.If the device or further details are received at a later date a supplemental medwatch will be sent.H6 component code: g07002.

• Brand Name: TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD
• 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: 17868462
• MDR Text Key: 324891685
• Report Number: 2210968-2023-07387
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Sex: Female