MAUDE Adverse Event Report: ETHICON INC. GYNECARE TVT-ABBREVO MINI LCM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Model Number TVTOML

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 07/22/2022

Event Type  malfunction  

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 retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.(b)(4).A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria for lot 3940998 and product code tvtoml.

Event Description

It was reported that a patient underwent an unknown procedure on (b)(6) 2022 and mesh was used.When the product was opened in theatre in preparation to be placed into the patient, the entire sling was hanging on a thread and the mesh split in half.The product was not used in the patient.No further information was provided.

Manufacturer Narrative

(b)(4).Date sent to fda: 09/14/2022.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 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.The device upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.

Manufacturer Narrative

(b)(4) date sent to fda: 10/25/2022 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 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: h3, h6 h3 analysis summary: received for evaluation was a part of tvtoml (tvt abbrevo) device, batch 3940998.The product was decontaminated and well packaged.The received device was manipulated, as it was not received in its original packaging, the blister is missing.- box and lid - the box and lid were received completely folded, the identification label is present in the two components and corresponds to lot number 3940998.No other damages were found.- trocars - no damages were detected during the evaluation.- blue mesh - it can be observed that the mesh was cut in two parts.After verification with a calibrated gauge, the mesh did not meet the requirements of neuchatel manufacturing, one part of the mesh is missing.No other damages were observed.- needles - the two needles have been verified and no damages were observed.- button of positioning loop - no damages were detected during the evaluation.- winged guide - no damages were detected during the evaluation.The batch record review had shown that the product was conforming to specifications at release.The defect on device seen during the product evaluation is aligned with the defect described in the event description ("the entire sling is was hanging on a thread and the mesh split in half").Based on the evaluation, this complaint is not a manufacturing issue.

• Brand Name: GYNECARE TVT-ABBREVO MINI LCM
• 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: 15284048
• MDR Text Key: 305356814
• Report Number: 2210968-2022-06884
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 10705031062368
• UDI-Public: 10705031062368
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K100936
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: TVTOML
• Device Catalogue Number: TVTOML
• Device Lot Number: 3940998
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2022
• 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