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

Model Number TVTRL

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/09/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).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: what is the lot number? the lot number is 3938406.Were there any patient consequences? there were no reported patient consequences.Please clarify, was the second tvtrl implanted during the same procedure or was a new surgery required? the second tvtrl was implanted in the same procedure.

Event Description

It was reported that a patient underwent a sling procedure on (b)(6) 2021 and the mesh was used.It was reported that the mesh slipped under the skin and had to be removed.It was reported that all the mesh was removed from the patient and a like device was used to complete the procedure.Additional information was requested.

Manufacturer Narrative

Product complaint # (b)(4).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: what is the lot number? the lot number is 3938406.Were there any patient consequences? there were no reported patient consequences.Please clarify, was the second tvtrl implanted during the same procedure or was a new surgery required? the second tvtrl was implanted in the same procedure.

Event Description

It was reported that a patient underwent a sling procedure on (b)(6) 2021 and the mesh was used.It was reported that the mesh slipped under the skin and had to be removed.It was reported that all the mesh was removed from the patient and a like device was used to complete the procedure.Additional information was requested.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 04/21/2022.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, 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: h4, h6.H6 component code: g07002 - device not returned.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.

• 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
• MDR Report Key: 12852922
• MDR Text Key: 285694201
• Report Number: 2210968-2021-11862
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 10705031062375
• UDI-Public: 10705031062375
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K132054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: TVTRL
• Device Catalogue Number: TVTRL
• Device Lot Number: 3938406
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/09/2021
• Initial Date FDA Received: 11/22/2021
• Supplement Dates Manufacturer Received: 03/26/2022
• Supplement Dates FDA Received: 04/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female