MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 VENTRALIGHT ST MESH; SURGICAL MESH

Catalog Number 5954600

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/01/2020

Event Type  malfunction  

Manufacturer Narrative

As reported, it is alleged that while attempting to implant a ventralight st mesh, it "did not look right".The subject device was returned for evaluation.Sample evaluation finds the st coating has separated from areas on the mesh.The separation has resulted in a void of the hydrogel barrier.No manufacturing anomalies were found.Initial evaluation identified that the mesh had been hydrated by the user, how long the mesh had been hydrated for is unknown.The instructions-for-use states the mesh should be hydrated for no more than 1-3 seconds prior to use and rolled immediately to protect the bioresorbable coating.Based on the event as reported and sample evaluation a definitive root cause of the reported event cannot be made.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 manufacturing lot.Note, the date of event provided is the best estimate based on the date of awareness of the reported event.

Event Description

It was reported that, during a hernia repair procedure, the ventralight st, "did not look right" and the product was deemed unusable.As reported, the or staff used another ventralight st mesh for the case without any issue.There was no reported patient harm/injury.

• Brand Name: VENTRALIGHT ST MESH
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 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: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 10784340
• MDR Text Key: 214539605
• Report Number: 1213643-2020-20028
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741031632
• UDI-Public: (01)00801741031632
• 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,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5954600
• Device Lot Number: HUDQ0828
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2020
• Date Manufacturer Received: 10/14/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2019
• 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
• Patient Outcome(s): Other