MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 VENTRALIGHT ST W/ ECHO 2; SURGICAL MESH

Catalog Number 5991520

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/24/2021

Event Type  malfunction  

Manufacturer Narrative

As reported, the st coating peeled about 1-2 mm from the edge of the bard/davol ventralight st w / echo 2 mesh.Information regarding mesh preparation including mesh hydration and trocar size used were not provided.Based on the information provided and without having the sample available for evaluation, no conclusions can be made.Review of manufacturing records confirms product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.To date, this is the only reported complaint from this manufacturing lot of (b)(4) units released for distribution in july, 2021.Should additional information be provided, a supplemental mdr will be submitted.Not returned - remains implanted.

Event Description

As reported, during a laparoscopic ventral hernia repair procedure on (b)(6) 2021, it was noted that the st coating peeled about 1-2 mm from the edge of the bard/davol ventralight st w / echo 2 mesh.As reported, the surgeon used a couple of additional fasteners/fixation to secure the st coating in place, over the mesh.As reported, there was no patient harm or injury as a result and the surgeon completed the case without any further issue.

• Brand Name: VENTRALIGHT ST W/ ECHO 2
• 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: 12591024
• MDR Text Key: 275197515
• Report Number: 1213643-2021-20348
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741131004
• UDI-Public: (01)00801741131004
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170294
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2022
• Device Catalogue Number: 5991520
• Device Lot Number: HUFS1711
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2021
• 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