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

Model Number TVTOML

Device Problem Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/29/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.

Event Description

It was reported that a patient underwent a sling procedure on (b)(6) 2020 and mesh was used.The surgeon opined that the mesh was too thin in the middle portion of the mesh and the blue ring was not positioned properly.The faulty mesh was removed and the procedure was completed using a like device with no adverse patient consequences reported.No additional information was reported.

Manufacturer Narrative

(b)(4).Date sent to fda: 11/11/2020.H3 analysis summary: the received device was manipulated as the lid was detached from its original blister and guides and needles were not present.Organic matter was visible on the mesh.There were damages in the middle of the mesh and the blue ring was inserted in one pore only.The defect on device seen during the product evaluation is aligned with the defect described in the event description ("mesh to thin in the middle portion and blue ring not properly positioned").Nevertheless, the defect identified is not linked to a manufacturing issue.In addition, a review of the batch manufacturing records was conducted, and no non-conformances related to the malfunction were identified.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.

• Brand Name: GYNECARE TVT-ABBREVO MINI LCM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10490688
• MDR Text Key: 205709016
• Report Number: 2210968-2020-06629
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 10705031062368
• UDI-Public: 10705031062368
• Combination Product (y/n): N
• PMA/PMN Number: K100936
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/14/2020

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: 12/31/2021
• Device Model Number: TVTOML
• Device Catalogue Number: TVTOML
• Device Lot Number: 3936050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2020
• Initial Date Manufacturer Received: 08/14/2020
• Initial Date FDA Received: 09/03/2020
• Supplement Dates Manufacturer Received: 10/22/2020
• Supplement Dates FDA Received: 11/11/2020
• Patient Sequence Number: 1