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

Catalog Number 810081L

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)

Patient Problems Purulent Discharge (1812); Unspecified Infection (1930); Obstruction/Occlusion (2422)

Event Date 01/01/2018

Event Type  Injury  

Event Description

It was reported that a patient underwent laparoscopic prolapse treatment, anterior and posterior promoto-fixation with conservation of the uterus (posterior and anterior hysteropexy) with tubal ligation and treatment of stress urinary incontinece on (b)(6)2016 and mesh was implanted.The patient reported experiencing intense stomach ache on the right side due to perforation of the rectum as a result of migration of a urinary mesh or promonto fixation.The patient had to undergo an initial emergency reconstructive operation in (b)(6) 2019.Then the total removal of the surgical material in (b)(6) 2021 which resulted in the resection of two thirds of the patient's rectum.The patient now suffers from constant pain and inability to have a bowel movement without medication.The patient already suffers from sed (unknown in 2016) and basedow's disease and is currently on disability.No further information is available as the patient contact details were not disclosed.

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 review of the batch manufacturing records was conducted, and no related non-conformances were identified.Related events captured via 2210968-2023-09956, 2210968-2023-09957, 2210968-2023-09958, and 2210968-2023-09960.

• Brand Name: GYNECARE TVT OBTURATOR W LASR
• 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: 18365356
• MDR Text Key: 331004559
• Report Number: 2210968-2023-09959
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 10705031062306
• UDI-Public: 10705031062306
• 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: 12/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Catalogue Number: 810081L
• Device Lot Number: 3894250
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2016
• 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 Age: 37 YR
• Patient Sex: Female