MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. VENTRIO MESH

Catalog Number 0010214

Device Problems Difficult to Insert (1316); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/02/2014

Event Type  malfunction  

Event Description

The following was reported to davol: it is alleged that while the surgeon was attempting to implant the ventrio mesh it tore as the surgeon grasped it with the grasper.As the damage to the material compromised the implant an mdr is being filed to document this event.As reported there was no patient injury and the device was removed without issue.

Manufacturer Narrative

The device has been returned to davol for evaluation; however, the evaluation has not yet been completed.Upon completion of the sample evaluation a supplemental mdr will be sent.

• Brand Name: VENTRIO MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; warwick RI
• Manufacturer (Section G): BARD SHANNON LIMITED; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: laura berg ; 100 crossings boulevard; warwick, RI 02886 ; 8005566756
• MDR Report Key: 3695438
• MDR Text Key: 21966314
• Report Number: 1213643-2014-00024
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100229
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0010214
• Device Lot Number: HUX10601
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/21/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/06/2014
• Initial Date FDA Received: 02/04/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2013
• 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