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

Catalog Number 5950008

Device Problems Material Separation (1562); Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/21/2019

Event Type  malfunction  

Manufacturer Narrative

Based on the event as reported and the sample evaluation, this complaint is confirmed with a use related root cause. As reported the user hydrated the mesh for several minutes prior to placement. Per the instructions-for-use, provided with the device, the "ventralex st hernia patch be completely immersed in sterile saline for 1-3 seconds immediately prior to placement in order to maximize the flexibility of the prosthesis. " to date this is the only reported complaint for this manufacturing lot (b)(4) units released for distribution in july, 2018. A review of the manufacturing records was performed and found that the lot was manufactured to specification.

Event Description

It was reported that during an open umbilical hernia repair on (b)(6) 2019 the surgeon attempted to place the ventralex st hernia patch but reported the "gel layer was rubbing off" as she was placing it in the patient. Another mesh was brought in and used successfully without further issue. There was no patient harm. In follow up with the contact it was reported that the mesh patch was hydrated for several minutes prior to placement.

• Brand Name: VENTRALEX ST
• 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: 8397037
• MDR Text Key: 138093398
• Report Number: 1213643-2019-01405
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101928
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/06/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 06/28/2020
• Device Catalogue Number: 5950008
• Device Lot Number: HUCT1464
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2019

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial