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

Catalog Number 0010301

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

As reported this was not an out of box failure, the surgeon inadvertently created the hole during the procedure. Attempts were made to obtain additional details regarding the reported event, however the contact was unable to provided any additional information. The sample was discarded by the user facility and is therefore unavailable for evaluation. 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. Device not returned.

Event Description

It was reported that during an umbilical hernia repair procedure, using a bard ventralex hernia patch the surgeon inadvertently made a hole in the mesh. The surgeon noticed the hole and the mesh was removed, another was brought in to complete the case. There was no patient injury, however if the surgeon had not noticed the hole and implanted the mesh, having a hole in the mesh may compromise the strength of the repair and has the potential to cause or contribute to patient injury.

• Brand Name: MESH - VENTRALEX
• 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 berg ; 100 crossings blvd.; warwick, RI 02886 ; 4018258462
• MDR Report Key: 6261099
• MDR Text Key: 65216866
• Report Number: 1213643-2017-00029
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132441
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility

Reporter Occupation

• Type of Report: Initial
• Report Date: 01/18/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 01/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 01/28/2020
• Device Catalogue Number: 0010301
• Device Lot Number: HUAU1681
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial