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

Catalog Number 0010302

Device Problems Difficult to Insert (1316); Folded (2630); Noise, Audible (3273)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/24/2013

Event Type  malfunction  

Event Description

As the surgeon was attempting to implant the hernia patch medium circle with strap, "the edges kept curling up and everyone at the field heard a crackling sound when the mesh was attempting to bend it to implant." the item was not used.

• Brand Name: VENTRALEX
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings boulevard; warwick RI 02886
• MDR Report Key: 3855375
• MDR Text Key: 4656383
• Report Number: 3855375
• Device Sequence Number: 1
• Product Code: FTL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/20/2014

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: Physician
• Device Catalogue Number: 0010302
• Device Lot Number: HUXJ0189
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/20/2014
• Event Location: Hospital
• Date Report to Manufacturer: 06/09/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/20/2014
• Patient Sequence Number: 1