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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. MESH - VENTRALEX SURGICAL MESH Back to Search Results
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.

 
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Brand NameMESH - VENTRALEX
Type of DeviceSURGICAL 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 Key7139940
MDR Text Key95933898
Report Number1213643-2017-01088
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
PMA/PMN NumberK132441
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 12/21/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/21/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/28/2020
Device Catalogue Number0010302
Device LOT NumberHUAT2555
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/05/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/30/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/17/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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