MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. VENTRALIGHT ST MESH SURGICAL MESH

Catalog Number 5954450

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Malfunction  

Manufacturer Narrative

The information provided is limited and the sample has not been returned. Requests for additional information, including sample return status have been made. Based on the information provided, and not having the sample to evaluated no conclusion can be made. It is unclear at this time what is meant by "the mesh began to fall apart" during attempted placement. However, typically this would indicate that the mesh was over or under hydrated causing an issue with the hydrogel (st) coating. Per the instructions-for-use the "ventralight ¿ st mesh should be hydrated for no more than 1-3 seconds just prior to laparoscopic placement. If sutures are being placed, attach the sutures to the ventralight ¿ st mesh before hydration. The prosthesis must be rolled immediately after hydration about its long axis (lengthwise) with the bioresorbable coating inside to protect the bioresorbable coating. " a review of the manufacturing records was performed and found that the lot was manufactured to specification. To date this is the only reported complaint for this production lot of (b)(4) units released for distribution in october, 2019. Should additional information be provided or if the sample is returned for evaluation, a supplemental emdr will be submitted.

Event Description

It was reported that "when the o. R. Staff attempted to place the bard ventralight st mesh inside the patient, the mesh began to fall apart. They were unable to continue using this particular mesh. The procedure was able to be completed using other mesh the surgery unit had on hand. " as reported, there was no patient injury.

• Brand Name: VENTRALIGHT ST MESH
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): BARD SHANNON LIMITED 3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: laura sundberg ; 100 crossings blvd.; warwick, RI 02886 ; 4018258462
• MDR Report Key: 9457318
• MDR Text Key: 193301672
• Report Number: 1213643-2019-12027
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (Y/N): N
• Reporter Country Code: US
• PMA/PMN Number: K101851
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,USER F

Reporter Occupation

• Type of Report: Initial
• Report Date: 12/12/2019

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 12/12/2019
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device Catalogue Number: 5954450
• Device LOT Number: HUDV0879
• Was Device Available For Evaluation?: No

Is The Reporter A Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/20/2019
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 10/18/2019
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial