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

Catalog Number	810041B
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	01/01/2024
Type of Reportable Event	Serious Injury
Additional 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.Additional information was requested and the following response was obtained: name of index surgical procedure? midurethral sling the diagnosis and indication for the index surgical procedure? stress urinary incontinence were any concomitant procedures performed? robotic-assisted total laparoscopic hysterectomy and bilateral salpingo-oophorectomy other relevant patient history/concomitant medications? n/a were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? no did the patient receive any prophylactic antibiotics pre-, intra- or post-operation? during procedure 2g ancef and 500 mg flagyl iv were given for antibiotic prophylaxis please describe any medical intervention performed including medication name and results.Macrobid 100 mg bid x 5 days what is the physician¿s opinion as to the etiology of or contributing factors to this event? post-op state, recent bladder instrumentation all risks for utis what is the patient's current status? recovered product code and lot number? 810041b; lot# 394667 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.
Event or Problem Description
It was reported that a patient underwent a robotic-assisted total laparoscopic hysterectomy and bilateral salpingo-oophorectomy on (b)(6) 2023 and mesh was implanted for stress urinary incontinence.On 01 jan 2024, a moderate urinary tract infection was noted.Macrobid 100 mg bid x 5 days was provided and the event was recovered/resolved without sequelae as of 10 jan 2024.This event was reported as possibly related to the study device and study procedure.Additional information was requested.
Additional 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.Corrected information: d1, d4, g4, h4.
Additional 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.Additional information: d4, h6 a review of the batch manufacturing records was conducted, and no related non-conformances were identified.

• Brand Name: GYNECARE TVT DEVICE
• 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: 19480161
• Report Number: 2210968-2024-05939
• Device Sequence Number: 4071627
• Product Code: OTN
• UDI-Device Identifier: 10705031000322
• UDI-Public: (01)10705031000322(11)230215(17)260131(10)3943667
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K012628
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup

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: 01/31/2026
• Device Catalogue Number: 810041B
• Device Lot Number: 3943667
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 06/15/2024; 07/12/2024
• Initial Report FDA Received Date: 06/06/2024
• Supplement Report FDA Received Date: 07/10/2024; 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2023
• 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: 71 YR
• Patient Sex: Unknown
• Patient Weight: 91 KG