MAUDE Adverse Event Report: ETHICON INC. VICRYL MESH 3X2CM; MESH, SURGICAL, POLYMERIC

Catalog Number VM302

Device Problem Peeled/Delaminated (1454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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."when removing the device from the sterile bag" is the sterile bag you are referring to the primary packaging? was the primary packaging intact? where there any holes in the packaging? please confirm the product code.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.

Event Description

It was reported that a patient underwent a dental procedure on an unknown date in 2019 and the mesh was implanted.When removing the device from the sterile bag the membrane disintegrated.A replacement device was used.There were no adverse patient consequences reported.

Manufacturer Narrative

Product complaint #: (b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Evaluation: an empty opened folder of product was returned for analysis.The issue sample was not received for analysis.As no mesh was returned for evaluation, the issue could not be investigated further.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.

• Brand Name: VICRYL MESH 3X2CM
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8528963
• MDR Text Key: 142519150
• Report Number: 2210968-2019-80501
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 04/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: VM302
• Device Lot Number: JA8BBZG0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2019
• Date Manufacturer Received: 04/01/2019
• Patient Sequence Number: 1