MAUDE Adverse Event Report: ETHICON INC. TVT W/ABDOMINAL GUIDES 1 PACK; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Catalog Number	810041A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by an attorney that the patient underwent a gynecological surgical procedure on (b)(6) 2005 and mesh was implanted, concurrently with dilation and curettage, endometrial ablation, and cystoscopy.It was reported that she experienced pain following the procedure.No additional information was provided.
Additional Manufacturer Narrative
Date sent to the fda: 11/10/2023.To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information prior to the required reporting date.This report does not reflect a conclusion by ethicon, 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.This event was previously submitted under ethicon mdr summary reporting exemption e2013037.Initial psr reporting period: august 1, 2016 through september 30, 2016 psr submission number: (b)(4).Psr report identifier: (b)(6).All event details will now be captured via emdr report number 2210968-2023-08725.

• Brand Name: TVT W/ABDOMINAL GUIDES 1 PACK
• Common Device Name: 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: 18108349
• Report Number: 2210968-2023-08725
• Device Sequence Number: 17567292
• Product Code: OTN
• UDI-Device Identifier: 10705031062283
• UDI-Public: 10705031062283
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K012628
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/10/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2009
• Device Catalogue Number: 810041A
• Device Lot Number: 1275447
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2023
• Initial Report FDA Received Date: 11/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2005
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 43 YR
• Patient Sex: Female