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

Model Number 810081

Device Problem Material Erosion (1214)

Patient Problem Erosion (1750)

Event Date 12/16/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria for lot 3939296 and product code 810081.

Event Description

It was reported that a patient underwent a urology procedure on (b)(6) 2021 and the mesh was implanted.It was reported that the tape was eroded at the site of contact with the urethra when the protective plastic was removed.It was also reported that the procedure was successfully completed.

Manufacturer Narrative

Product complaint#: (b)(4).Date sent to the fda: 04/21/2022.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, 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.Additional information was requested and the following was obtained: the patient demographic info: age, weight, bmi at the time of index procedure the diagnosis and indication for the initial surgical procedure? were there any patient consequences/symptoms following the index surgical procedure? if so, what was the onset date? other relevant patient history/concomitant medications the initial approach for the index surgical procedure? any concurrent procedure/device implantation? were there any intra-operative complications? mesh exposure site/location, symptoms and diagnostic confirmation? describe any medical/surgical intervention for exposure including dates and surgical findings.What is physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? were there any patient consequences/symptoms following the index surgical procedure? not.The initial approach for the index surgical procedure? vaginal were there any intra-operative complications? not.

• Brand Name: GYNECARE TVT OBTURATOR
• 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
• MDR Report Key: 13262039
• MDR Text Key: 288886989
• Report Number: 2210968-2022-00433
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 10705031000346
• UDI-Public: 10705031000346
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K033568
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/21/2022

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: 05/31/2022
• Device Model Number: 810081
• Device Catalogue Number: 810081
• Device Lot Number: 3939296
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/16/2021
• Initial Date FDA Received: 01/14/2022
• Supplement Dates Manufacturer Received: 04/01/2022
• Supplement Dates FDA Received: 04/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female