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 Date 03/31/2020

Event Type  Malfunction  

Manufacturer Narrative

At this time, no conclusion can be made. While the sample evaluation is anticipated it has not get begun. To date this is the only reported complaint for this manufacturing lot. Review of the manufacturing records is in process. When the investigation has been completed, a supplemental emdr will be submitted.

Event Description

As reported, while performing a laparoscopic incisional hernia repair procedure, it was discovered that the adhesive coating was peeling off the ventralight st mesh. There was a minimal delay and the procedure was completed using another device. There was no reported 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: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 4018258495
• MDR Report Key: 10075479
• MDR Text Key: 193038765
• Report Number: 1213643-2020-04942
• Device Sequence Number: 1
• Product Code: FTL
• 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

• Type of Report: Initial,Followup
• Report Date: 06/10/2020

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 05/20/2020
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device EXPIRATION Date: 04/28/2020
• Device Catalogue Number: 5954450
• Device LOT Number: HUCP2569
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 05/18/2020

Is The Reporter A Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/01/2020
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 05/09/2018
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial