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

Model Number 810081L

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

Patient Problems Inflammation (1932); Pain (1994); Ambulation Difficulties (2544)

Event Date 04/01/2015

Event Type  Injury  

Event Description

It was reported that a patient underwent an unknown procedure for urinary leakage on (b)(6) 2009 and mesh was implanted.The patient reported experiencing acute pain in the right obturator muscle while sitting on a hard floor and 4 weeks later, hyperalgic sciatica occurred while raising arms.The patient reported being bedridden 15 days without being able to walk or sit and feeling of electric shocks throughout the leg along with phlebitis on the same side.The patient further reported that the pain which occurred in (b)(6) 2015 was down in the groin, on the inside of the thigh almost to the knee and was unbearable for 3 months, forbidding her to sit.The patient underwent medical explorations (radio,echo) which showed nothing and unspecified treatments were ineffective.An osteo was able to locate the place of the pain and provide little relief.The patient explained that the pain became chronic and could no longer ride a bike or sit long in some seats.The patient reported the reason for pain was discovered during a petscan last november (diagnosis of lymphoma).The hematologist sent the patient to consult a gynecologist, then a urologist who opined that the inflammation was due to the strip placed in 2009.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.A manufacturing record evaluation was performed for the finished device batch, and no non-conformances were identified.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.(b)(4).

• 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: 14957784
• MDR Text Key: 295502410
• Report Number: 2210968-2022-05275
• 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
• Report Date: 07/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2010
• Device Model Number: 810081L
• Device Catalogue Number: 810081L
• Device Lot Number: 3352382
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2009
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female