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

Catalog Number TVTRL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cyst(s) (1800); Urinary Tract Infection (2120); Unspecified Kidney or Urinary Problem (4503); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 03/17/2023

Event Type  Injury  

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 was obtained: can you identify the product code and lot number of the product that was used? tvtrl, 3943025.Please confirm there was no medical or surgical intervention performed to treat the cyst (product removed; re-operation; re-closure; prescription medication)? if so, please specify.No medical intervention.If medication was required, please clarify if it was prescription strength.No what is the most current patient status? ongoing.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 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 required to treat the voiding dysfunction 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? 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 Description

It was reported that a patient underwent an unspecified procedure on (b)(6) 2023 and mesh was implanted.On (b)(6) 2023, labial cyst was noted.On (b)(6) 2023, mild voiding dysfunction was noted.The patient received unspecified drug therapy and pelvic floor pt for the voiding dysfunction.The events were reported as unlikely related to the study device and possibly related to the study procedure.Additional information has been requested.

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 received: adverse event term: recurrent uti.Start date: (b)(6) 2024.Severity: mild.Relationship to study device: unlikely.Relationship to primary study procedure: possible.Intervention/treatment: drug therapy: yes.Outcome: not recovered/not resolved.Adverse event term: levator spasm, start date: (b)(6) 2023, severity: mild, relationship to study device: unlikely, relationship to primary study procedure: possible, intervention/treatment: drug therapy: yes, outcome: not recovered/not resolved.

• Brand Name: TVT EXACT RETROPUBIC SYSTEM
• 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 ; 9083863534
• MDR Report Key: 18085532
• MDR Text Key: 327547019
• Report Number: 2210968-2023-08614
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 10705031062375
• UDI-Public: 10705031062375
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: TVTRL
• Device Lot Number: 3943025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/24/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 35 YR