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

Model Number TVTRL

Device Problem Migration (4003)

Patient Problem Erosion (1750)

Event Date 04/01/2022

Event Type  Injury  

Event Description

It was reported that a patient underwent a gynecological procedure on (b)(6) 2021 and mesh was implanted.On (b)(6) 2022, mesh erosion was noted.The patient received unspecified drug therapy.The erosion has been reported as a causal relationship with the study procedure, but not related to the study device.The event has been recovered/resolved without sequelae as of (b)(6) 2022.Additional information was 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 site/location, symptoms and diagnostic confirmation of the mesh erosion noted on (b)(6) 2022.Describe the drug therapy provided for this mesh erosion including medication name and results.Was any surgical intervention performed? if so, please provide the date and findings.What is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? 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.(b)(4).A manufacturing record evaluation was performed for the finished device batch, and no non-conformances were identified.Related events captured via 2210968-2022-09423.

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 received: please provide the site/location, symptoms and diagnostic confirmation of the mesh erosion noted on 05/06/2022: patient had no symptoms, mesh erosion was detected by a speculum describe the drug therapy provided for this mesh erosion including medication name and results: patient had no therapy from (b)(6)2022 until (b)(6)2022.Local estrogenization was recommended using ovestin creme 1mg from (b)(6)2022 till (b)(6)2022 (once a day).Was any surgical intervention performed? if so, please provide the date and findings: no.What is the physician¿s opinion as to the etiology of or contributing factors to this event? lack of estrogenization of the vaginal epithelium and increased physical exercises what is the patient's current status?: patient has no complaints.Related events captured via 2210968-2022-07212 and 2210968-2022-09423.

• 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 INC. - NEUCHATEL; puits godet 20; neuchatel 2000 ; SZ 2000
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15791362
• MDR Text Key: 303630137
• Report Number: 2210968-2022-09423
• 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: Foreign,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: TVTRL
• Device Catalogue Number: TVTRL
• Device Lot Number: 3938802
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2021
• 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: 58 YR
• Patient Sex: Female