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	Pain (1994)
Date of Event	10/27/2023
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: can you identify the product code and lot number of the product that was used? model# 810041b; lot# 3943979.Was there any medical or surgical intervention performed (product removed; re-operation; prescription medication)? if so, please specify.No medical or surgical intervention.If medication was required, please clarify if it was prescription strength.Pain well managed with tylenol and ibuprofen as needed during the day and oxycodone before bed.This is standard post-op care.No additional pain medication prescribed.What is the most current patient status? at the time of the post-discharge follow-up call, the patient reported her pain as an 8/10 on the wong baker scale.Pain is bad with sitting.Recommended warm/cold compresses, alternating, and no more than 20 minutes at a time.Advised to contact the provider¿s office if pain worsens or persists.As of (b)(6) 2023, no additional calls/complaints received.The patient is scheduled for a follow-up visit on (b)(6) 2023.Attempts are being made to obtain the following additional 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 gender, weight, bmi at the time of index procedure name of index surgical procedure? the diagnosis and indication for the index surgical procedure? were any concomitant procedures performed? other relevant patient history/concomitant medications? please describe any medical intervention given for pain management including medication name and results.What is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? surgeon¿s name? facility name? 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.A review of the batch manufacturing records was conducted, and no related non-conformances were identified.
Event or Problem Description
It was reported that a patient underwent a sling procedure on (b)(6) 2023 and mesh was implanted.On (b)(6) 2023, the patient experienced mild post-operative pain.Standard post-op care was provided and no additional pain medication was prescribed.On (b)(6) 2024, moderate back pain was noted.Unspecified drug therapy was provided and mri was performed.As of (b)(6) 2023, no additional calls/complaints were received.The patient is scheduled for a follow-up visit on (b)(6) 2023.This event was reported as unlikely related to the study device, but possibly related to the study procedure.Additional information has been 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.Additional information was requested and the following response was provided: please provide the patient's demographic information including gender, weight, bmi at the time of index procedure female, 190lbs, bmi 31.62kg.Name of index surgical procedure? mid-urethral 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 salpingoophorectomy; robotic assisted laparoscopic sacrocolpopexy; posterior vaginal repair; cystoscopy.Other relevant patient history/concomitant medications? pelvic organ prolapse please describe any medical intervention given for pain management including medication name and results.Mri recommended to assess.Nsaids, lidocaine patch, heat pack.If pain acutely worse or she develops any constitutional symptoms, patient advised to go to the ed.What is the physician¿s opinion as to the etiology of or contributing factors to this event? unclear etiology but started a couple of weeks after the surgery.No fever, chills, discharge.What is the patient's current status? patient has noted some improvement on nsaids.Mri has not yet scheduled.
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 was requested, and the following was obtained: updated.Log line: 1 end date : 05 dec 2023 outcome : recovered/resolved without sequelae.

• 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: 19472420
• Report Number: 2210968-2024-05876
• Device Sequence Number: 11611502
• Product Code: OTN
• UDI-Device Identifier: 10705031000322
• UDI-Public: 10705031000322
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/10/2026

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: 02/28/2026
• Device Catalogue Number: 810041B
• Device Lot Number: 3943979
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2024
• Supplement Date Received by Manufacturer: 06/11/2024; 03/24/2026
• Initial Report FDA Received Date: 06/05/2024
• Supplement Report FDA Received Date: 06/28/2024; 04/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/28/2023
• 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: 51 YR
• Patient Sex: Unknown
• Patient Weight: 86 KG