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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 Problems Detachment of Device or Device Component (2907); Torn Material (3024)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/30/2015
Event Type  malfunction  
Manufacturer Narrative
This initial mdr is being submitted as a result of a retrospective review of davol¿s mdr decisions and the initial decision not to report the event is being revised to reflect updated company procedures. Confirmed, user related. The device is physically damaged and has evidence of attempted use as there is dry blood on the patch. The mesh is torn and damaged and appears to have been exposed to physical force to cause this condition to present. No anomalies were noted with the patch that would indicate a manufacturing related cause for the problem the information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
 
Event Description
They informed us that they found a device with the memory ring partially detached. They did not used it on a patient, using another of the same device code/lot without problem. Sample to be returned for evaluation.
 
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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 Key6731285
MDR Text Key80692627
Report Number1213643-2017-00427
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K132441
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Service Personnel
Type of Report Initial
Report Date 07/21/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/21/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number0010301
Device Lot NumberHUZC1632
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/08/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/01/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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