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

Catalog Number 0010302

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/06/2017

Event Type  malfunction  

Manufacturer Narrative

The ventalex hernia patch was returned for evaluation.As reported it was evident that if had been placed in the body and manipulated by the surgeon.The problem presented prior to the user having sutured the implant in place.The reported condition was confirmed as a loose monofilament used to sew the patch together.The inner recoil ring remains within the mesh layers containment sleeve.Nothing has come free from the implant.Visual examination of the monofilament indicate the knot had been present, to close the sew line.At this time no definitive conclusions can be made.The forces applied to the device may have contributed to the problem identified.A review of the manufacturing records was performed and found that the lot was manufactured to specification.(b)(4).

Event Description

It was reported that during an umbilical hernia repair a bard/davol ventralex hernia patch was placed in the patient and situated to the hernia defect.At that time the surgeon noticed that the patch had ¿loose¿ stitching.As the implant was compromised the surgeon removed it from the body and another bard/davol ventralex hernia patch was implanted without issue.There was no patient injury as a result of this situation.

• 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 sundberg ; 100 crossings blvd.; warwick, RI 02886 ; 4018258462
• MDR Report Key: 7139940
• MDR Text Key: 95933898
• Report Number: 1213643-2017-01088
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741016479
• UDI-Public: (01)00801741016479
• Combination Product (y/n): N
• PMA/PMN Number: K132441
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2020
• Device Catalogue Number: 0010302
• Device Lot Number: HUAT2555
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2016
• 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