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

Catalog Number 810081L

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

Patient Problems Bacterial Infection (1735); Incontinence (1928); Pain (1994); Urinary Tract Infection (2120); Anxiety (2328); Discomfort (2330); Depression (2361); Ambulation Difficulties (2544); Decreased Sensitivity (2683); Insufficient Information (4580)

Event Date 10/01/2015

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 review of the batch manufacturing records was conducted, and no related non-conformances were identified.Related events captured via 2210968-2023-09883, 2210968-2023-09884, 2210968-2023-09885, 2210968-2023-09886, 2210968-2023-09887.

Event Description

It was reported that a patient underwent a sling procedure for urinary incontinence on (b)(6) 2015 and mesh was implanted.The patient reported that after the urinary tape placement, they couldn't feel the left leg and had difficulty moving it.When the patient got home, they had severe pain in the vagina and pelvis, as well as an inability to sit up.The patient further reported experiencing difficulty urinating, and because of the pain the patient had to urinate standing up.The patient went to the emergency room to complain about the pain, but they only gave pain medication every time.The doctor took the patient for a consultation twice before the scheduled medical check-up to verify the cause of pain, but without giving any answers or solutions to the problems.The doctor told the patient at the time that the tape couldn't be removed.After the placement of the tape, and for 4 years and until the partial removal of the vaginal part of the tape, the patient reported having the following problems: pain inside the pelvis, dyspareunia, recurrent urinary tract infections, pyelonephritis, repeated vaginal mycoses for 4 years, difficulty remaining in a sitting position, groin pain during and after walking, constant pain in left thigh, loss of clitoral sensation during sexual relations, weight gain due to movement difficulties, anxiety attacks and depression.Since the partial removal of the vaginal part of the tape and until now, some of these problems have gotten worse.Currently, the patient has the following problems: pain in both groins, diffuse pain inside the pelvis, vaginal pain when sitting, pain during and after sexual intercourse, sensation of electricity in both legs (from the feet to the buttocks), pain in the legs and inability to stay cross-legged, difficulty staying in the same position due to pain, liver and pancreas problems due to treatments for infections and pain, state of anxiety, insomnia, depressive state, deterioration of quality of life and degradation, reduction and strong limitations of sexuality.No further information is available as the patient contact details were not disclosed.

• 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: 18351491
• MDR Text Key: 330811925
• Report Number: 2210968-2023-09885
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2016
• Device Catalogue Number: 810081L
• Device Lot Number: 3865489
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2015
• 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