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

Catalog Number 5954790

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The sample was discarded by the user facility, therefore we are unable to perform an evaluation.Based on the information provided the surgeon hydrated the mesh for 5-7 seconds.Per the instructions-for-use the mesh should be hydrated for no more that 1-3 seconds.The surgeon stated that the mesh was not over hydrated, however the sample was not provided for evaluation and it is unclear if this may have contributed to the alleged hydrogel separation.At this time no definitive conclusion can be made.A review of the manufacturing records was performed and found that the lot was manufactured to specification.No manufacturing issues associated to the reported event were found in the reviewed lot.Dhr review showed all components for the lot met the specifications and there was no rework or other manufacturing abnormalities that may have contributed to this complaint.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.Not returned.

Event Description

It was reported that while placing a bdi surgery / davol ventralight st mesh in the patient during a laparoscopic ventral hernia repair case the "sepra barrier (hydrogel) came off in chunks." as reported the surgeon hydrated the mesh for 5 - 7 seconds in sterile, room temperature saline and introduced the mesh through a skin incision.The surgeon reports that the mesh was not over hydrated.The mesh was removed and discarded.The case was completed with another ventralight st mesh.The surgeon has used this product for several years, and is familiar with the technology and technique.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: 7491861
• MDR Text Key: 107574767
• Report Number: 1213643-2018-01357
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741031663
• UDI-Public: (01)00801741031663
• 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: Other
• Type of Report: Initial
• Report Date: 05/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2020
• Device Catalogue Number: 5954790
• Device Lot Number: HUCN1778
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2018
• 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