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

Catalog Number	810041BL
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Erosion (1750); Pain (1994); Abnormal Vaginal Discharge (2123)
Date of Event	01/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure the diagnosis and indication for the index surgical procedure? were any concomitant procedures performed? what was the initial approach for the index surgical procedure? were there any intra-operative complications? other relevant patient history/concomitant medications? please provide the mesh exposure site/location, symptoms and diagnostic confirmation.Describe any medical/surgical intervention for the exposure including dates and findings.Was the exposed mesh excised? were any deficiencies or anomalies noted with mesh device? what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? attempts are being made to retrieve the device.To date the device has not been 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 sling procedure on (b)(6) 2014 and mesh was implanted.Reportedly prosthetic exposure occurred in 2021 and had attempted recovery on 2021.Recurrence of prosthetic exposure on 2025.Current condition of the patient: reoperation on (b)(6) 2025 for partial excision of suburethral strip.Additional information has been requested.
Additional Manufacturer Narrative
Product complaint # (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: b7, d9, h3, h4, h6.Additional information was requested and the following was obtained: the diagnosis and indication for the index surgical procedure? stress urinary incontinence were any concomitant procedures performed? no.What was the initial approach for the index surgical procedure? retropubic.Were there any intra-operative complications? no.Other relevant patient history/concomitant medications? had other vaginal prosthetic exposures of other materials (for prolapse cure) please provide the mesh exposure site/location, symptoms and diagnostic confirmation.Vaginal prosthetic exposure on a colpotomy scar.Pain and leucorrhea describe any medical/surgical intervention for the exposure including dates and findings.Excision: vaginal prosthetic exhibition (b)(6) 2025.Was the exposed mesh excised? yes.Were any deficiencies or anomalies noted with mesh device? no.What is the physician¿s opinion as to the etiology of or contributing factors to this event? indeterminate.What is the patient's current status? she's fine.H3 investigation summary: neuchatel team received for evaluation one product of gynecare product code 810041bl and lot number 3752111.An investigation was performed on received product and on the batch record file.The product was decontaminated and well packaged.The received device was manipulated and ex-planted as original packaging and all components were missing.Only the remaining part of the mesh was visible with lot of organic matter around.Based to the evaluation, this complaint is not related to a manufacturing problem.The defect observed during the evaluation corresponds to the description of the event but cannot be confirmed with the received product.The product was conforming to specifications at the release.No nonconformance will be opened.Events of this type are trended regularly.A manufacturing record evaluation was performed for the finished device lot number, and no related non-conformances were identified.
Additional Manufacturer Narrative
Product complaint # (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: h6.

• Brand Name: GYNECARE TVT RETROPUBIC 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: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 22396922
• Report Number: 2210968-2025-07867
• Device Sequence Number: 20058870
• Product Code: OTN
• UDI-Device Identifier: 10705031062290
• UDI-Public: (01)10705031062290(17)170131(10)3752111
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K012628
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other
• 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: 01/31/2017
• Device Catalogue Number: 810041BL
• Device Lot Number: 3752111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2025
• Supplement Date Received by Manufacturer: 08/04/2025; 08/04/2025
• Initial Report FDA Received Date: 07/03/2025
• Supplement Report FDA Received Date: 08/29/2025; 09/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2014
• 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: 64 YR
• Patient Sex: Female
• Patient Weight: 70 KG