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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 0010301
Device Problem Material Separation (1562)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/04/2016
Event Type  Malfunction  
Manufacturer Narrative

This initial mdr is being submitted as a result of a retrospective review of davol¿s mdr decision and the initial decision not to report the event is being revised to reflect updated company procedures. It was reported to davol that when the surgeon attempted to place the ventralex mesh and it fell apart. No patient injury was reported due to this event. Observation confirmed the pdo ring containment sleeve was partially detached from the mesh and the mesh was damaged. The positioning strap was still attached. Damage is consistent with handling related issue. It appears that when attempting to position the mesh the device was inadvertently damaged. A review of the manufacturing records was performed and found that the lot was manufactured to specifications. The root cause was undetermined.

 
Event Description

Alleged when the surgeon attempted to place the ventralex mesh it "fell apart. " no patient injury.

 
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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
andrew topoulos
100 crossings blvd.
warwick, RI 02886
4018258495
MDR Report Key6740711
MDR Text Key80937057
Report Number1213643-2017-00433
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK132441
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation
Type of Report Initial
Report Date 07/25/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/25/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/28/2019
Device Catalogue Number0010301
Device LOT NumberHUZI1261
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/13/2016
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/04/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/14/2015
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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