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 Itching Sensation (1943); Burning Sensation (2146)

Event Date 01/01/2023

Event Type  Injury  

Event Description

It was reported that a patient underwent a sling procedure on (b)(6) 2021 and mesh was implanted.Starting in (b)(6) 2023, the patient experienced moderate burning and itching vaginally.Unspecified drug therapy was performed.This event was reported as not related to the study device and unlikely 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.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? onset date of the burning/itching? please describe the drug therapy performed 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? country of event? product code and lot number? 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.Updated information received: adverse event term: burning and itching vaginally: burning vaginally.Additional information received: adverse event term: itching vaginally start date: (b)(6) 2023.Severity: moderate.Relationship to study device: not related.Relationship to primary study procedure: unlikely.Drug therapy: yes.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.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 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, 72kg, 25.2 bmi name of index surgical procedure? insertion of a tension-free suburethral retropubic sling tvt exact and intraoperative cystoscopy the diagnosis and indication for the index surgical procedure? stress incontinence grade 3 confirmed with urodynamic testing were any concomitant procedures performed? no other relevant patient history/concomitant medications? 3x ab curettage ( years 1994,1995,1996 day and month unknown), cesarean section 16.08.1998, operative lapararoscopy for anamnestic uterine malformation (year 1995 date and month unknown), disc prolapse l4/l5 (b)(6) 2020 (no surgery), stillbirth (b)(6) 1997, birth with ve (vacuum extraction) (b)(6) 2002, depressio (b)(6) 1999.Onset date of the burning/itching? (b)(6) 2023 (day unknown).Please describe the drug therapy performed including medication name and results.Updated information after phone contact with patient on (b)(6) 2023.Döderlein vaginal capsules (one capsule per week) were recommended by her general practitioner and were taken from (b)(6) 2023 until (b)(6) 2023.Gynoflor was recommended by her gynecologist on (b)(6) 2023.After her condition hadn¿t improved she started with gynoflor (vaginal tablets 0-0-1) on (b)(6) 2023 for 6 days.Now the itching and burning have subsided.Subject has scheduled an appointment with a urologist for (b)(6) 2023 because according to her gynecologist (on (b)(6) 2023) the edge of the urinary bladder appeared abnormal on ultrasound.What is the physician¿s opinion as to the etiology of or contributing factors to this event? there is actually no proven connection between the vaginally itching/ burning and the product (tvt exact) or procedure.Patient will inform the site on (b)(6) 2023.What is the patient's current status? now the itching and burning have subsided.Country of event? austria.Product code and lot number? gyn care tvt exact lot:3938583.

• 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: 17720944
• MDR Text Key: 323093606
• Report Number: 2210968-2023-06581
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 10705031062375
• UDI-Public: 10705031062375
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 02/28/2022
• Device Catalogue Number: TVTRL
• Device Lot Number: 3938583
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/04/2023
• Initial Date FDA Received: 09/11/2023
• Supplement Dates Manufacturer Received: 09/19/2023; 09/29/2023; 11/21/2023
• Supplement Dates FDA Received: 09/28/2023; 10/12/2023; 11/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2021
• 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: 72 KG