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

Catalog Number 810041BL

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

Patient Problems Fever (1858); Incontinence (1928); Inflammation (1932); Pain (1994); Scar Tissue (2060); Urinary Tract Infection (2120)

Event Date 12/07/2022

Event Type  Injury  

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 ¿ device not returned.A manufacturing record evaluation was performed for the finished device batch, and no non-conformances were identified.

Event Description

It was reported that a patient underwent an unspecified procedure on (b)(6)2014 and mesh was implanted.The patient experienced recurrent back pain, repeated bacterial and bacterial cystitis.Umpteenth bacterial cystitis with a temperature of 39.8.The patient went to the emergency room and received intravenous antibiotics and painkillers because the patient had pyelonephritis.Additionally, the patient experienced vaginal pain, pelvic pain, left groin pain and pain with coitus, urinary incontinence, urinary tract infections and incomplete bladder emptying.The entire implant was removed on (b)(6)2023.No further information is available as the reporter contact details were not disclosed.

• Brand Name: GYNECARE TVT RETROPUBIC DEVICE
• 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: 17146508
• MDR Text Key: 317458413
• Report Number: 2210968-2023-04391
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K012628
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other
• Type of Report: Initial

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: 06/30/2017
• Device Catalogue Number: 810041BL
• Device Lot Number: 3785602
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/06/2023
• Initial Date FDA Received: 06/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2014
• 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