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 sample has not been returned for evaluation, as such a definitive conclusion cannot be made.Events of this nature are typically associated to the user not hydrating the mesh as instructed in the instructions-for-use.However, without having the sample to evaluate no conclusion can be made.There is no indication from the investigation activities performed that would indicate a malfunction of the device occurred.To date this is the only reported complaint for this manufacturing lot of 288 units released for distribution in (b)(6) 2018.A review of the manufacturing records was performed and found that the lot was manufactured to specification not returned.

Event Description

It was reported that a bard ventralight st mesh was being used during a robotic assisted laparoscopic umbilical hernia repair.As reported the mesh was rolled and inserted down a 12mm trocar and while attempting to unroll the mesh in the abdominal cavity the st (hydrogel) coating peeled off.Another mesh was used to complete the case.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: 8132572
• MDR Text Key: 129589383
• Report Number: 1213643-2018-04396
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741031618
• UDI-Public: (01)00801741031618
• 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: 12/05/2018

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: 06/28/2020
• Device Catalogue Number: 5954450
• Device Lot Number: HUCT1428
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/13/2018
• Initial Date FDA Received: 12/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2018
• 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