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

Catalog Number 5954810

Device Problems Contamination (1120); Material Separation (1562)

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

Event Date 08/19/2021

Event Type  malfunction  

Manufacturer Narrative

As reported, during the preparation for use of the ventralight st mesh, the user noted a gel-like ¿foreign material¿ on the mesh.Subsequent information received, indicates that the reported "foreign material" is possibly referring to the st gel coating of the mesh.The tacky condition of the returned sample for evaluation is consistent with the mesh having been hydrated, also four sutures had been attached to the returned mesh by the user.In addition, the hydrated mesh was received folded in half with the st coating inwards.A visual examination of the returned sample did not identify any foreign matter on the sample.Some hydrogel st coating was noted to be separated from the mesh.Separation of the st coating is not unexpected based on the hydrated tacky mesh being folded upon itself during transit of the sample return.However, based on the as reported event it appears at least some of the st coating separation occurred during handling of the mesh directly following hydration.Details regarding the users method of preparing and hydrating the mesh have not been provided by the reporter.Per the instructions-for-use (ifu) 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.Review of manufacturing records provided 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 september 2020.

Event Description

It was reported that immediately after opening the bard/davol ventralight st when attaching the needle thread to the mesh, it was noticed that a gel-like foreign material was attached.It was reported that another device was used to complete procedure.There was no reported patient injury.Subsequent information received, indicates that the reported "foreign material" is possibly referring to the st gel coating of the mesh.

• 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: 12475771
• MDR Text Key: 271520109
• Report Number: 1213643-2021-20327
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741031687
• UDI-Public: (01)00801741031687
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K101851
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2022
• Device Catalogue Number: 5954810
• Device Lot Number: HUET1643
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2020
• 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