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 Pain (1994); Urinary Tract Infection (2120); Unspecified Kidney or Urinary Problem (4503)

Event Date 11/28/2023

Event Type  Injury  

Event Description

It was reported that a patient underwent a sling procedure on (b)(6) 2023 and mesh was implanted.On (b)(6) 2023, mild dysuria was noted and unspecified drug therapy was provided.This event was reported as possibly related to the study device and study procedure.On (b)(6) 2023, moderate acute post-op pain was noted.This event was reported as possibly related to the study device and probably related to the study procedure.The dysuria and acute post-op pain have not been resolved.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.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? what was the initial approach for the index surgical procedure? were any concurrent devices implanted? were there any intra-operative complications? please describe any medical intervention given 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? product code and lot number? 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.

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.A review of the batch manufacturing records was conducted, and no related non-conformances were identified.

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: urinary tract infection start date: 06 mar 2024 severity: mild relationship to study device: possible relationship to primary study procedure: possible drug therapy: yes outcome: not recovered/not resolved adverse event term: voiding dysfunction start date: 10 jan 2024 severity: mild relationship to study device: possible relationship to primary study procedure: possible intervention/treatment: none outcome: not recovered/not resolved.

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: dysuria.End date: blank: 10 jan 2024.Outcome: not recovered/not resolved: recovered/resolved without sequelae adverse event: acute post-op pain.End date: blank: 10 jan 2024.Outcome: not recovered/not resolved: recovered/resolved without sequelae.Additional information was requested and the following was obtained: please provide the patient's demographic information including gender, weight, bmi at the time of index procedure female, 189lbs, 28.83.Name of index surgical procedure? sling operation for stress incontinence.The diagnosis and indication for the index surgical procedure? stress incontinence.Were any concomitant procedures performed? yes, cystoscopy.Other relevant patient history/concomitant medications? what was the initial approach for the index surgical procedure? retropubic.Were any concurrent devices implanted? no.Were there any intra-operative complications? none.Please describe any medical intervention given including medication name and results.Ciprofloxacin - antibiotic.What is the physician¿s opinion as to the etiology of or contributing factors to this event? urinary tract infection.What is the patient's current status? recovered.Product code and lot number? tvtrl 3943522.

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.Updated information received: adverse event term: urinary tract infection start date: (b)(6) 2024.End date : blank (b)(6) 2024.Outcome : not recovered/not resolved; recovered/resolved without sequelae.

• 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: 18494179
• MDR Text Key: 332677186
• Report Number: 2210968-2024-00322
• 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,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
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: TVTRL
• Device Lot Number: 3943522
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/20/2023
• Initial Date FDA Received: 01/11/2024
• Supplement Dates Manufacturer Received: 01/19/2024; 02/08/2024; 03/20/2024
• Supplement Dates FDA Received: 02/01/2024; 02/08/2024; 03/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2023
• 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: 48 YR
• Patient Sex: Female
• Patient Weight: 86 KG