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

Catalog Number 5954810

Device Problems Material Separation (1562); Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Based on the event as reported, after hydration the user placed the mesh down on top of the packaging and did not roll the mesh immediately after hydration to protect the hydrogel st coating as prescribed in the instructions-for-use.As such this complaint is confirmed for use related error with no malfunction of the device.To date no other complaints have been reported for this lot of (b)(4) units.As reported the sample is available for return and has not yet been received.However, the sample is not required for root cause determination.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.".

Event Description

It was reported that a bard ventralight st was being prepared for a robotic ventral hernia repair.As reported the mesh was hydrated and then placed on the mesh packaging.When the operating room tech attempted to remove the mesh from the packaging the hydrogel st coating peeled off the mesh.Another mesh was used to complete the repair.There was no injury to the patient.

• 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: 8513480
• MDR Text Key: 141904971
• Report Number: 1213643-2019-02965
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741031687
• UDI-Public: (01)00801741031687
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2020
• Device Catalogue Number: 5954810
• Device Lot Number: HUCV0548
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2018
• 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