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

Model Number TVTRL

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/06/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Analysis summary: neuchâtel team received for evaluation one sub-assembly of tvtrl, batch (b)(4), composed of two white plastic needles, blue prolene mesh and plastic sheath.The received device was manipulated and was not in its original blister.It was strongly folded.The plastic sheath on both extremities of the mesh was ripped on the mesh's edge at the exact position where the mesh was folded.The identified defect is not linked to a manufacturing issue.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria for lot 3935246 and product code tvtrl.

Event Description

It was reported that a patient underwent a gynecological procedure on (b)(6) 2020 and mesh was used.After unpacking the mesh, the surgeon noticed the protective cover of the mesh was damaged.The procedure was completed using another like device.There were no adverse patient consequences reported.

• Brand Name: TVT EXACT RETROPUBIC SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20; neuchatel ; SZ
• Manufacturer Contact: elba bello ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 9082183429
• MDR Report Key: 10087859
• MDR Text Key: 192015423
• Report Number: 2210968-2020-04108
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 10705031062375
• UDI-Public: 10705031062375
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K132054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/12/2020

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: 08/31/2020
• Device Model Number: TVTRL
• Device Catalogue Number: TVTRL
• Device Lot Number: 3935246
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2020
• Initial Date Manufacturer Received: 05/12/2020
• Initial Date FDA Received: 05/26/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1