BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTRALEX 6.4CM X 6.4CM

    MDR report key: 2021765 · Received March 11, 2011

    Report

    Report Number
    MW5019811
    Event Type
    Injury
    Date Received
    March 11, 2011
    Date of Event
    January 14, 2011
    Report Date
    March 11, 2011
    Manufacturer
    BARD
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    SLIDING HERNIA REPAIR (B)(6) 2005. BARD VENTRALEX SURGICAL PATCH USED TO REPAIR. SMALL BOWEL OBSTRUCTION, SURGICALLY CORRECTED (B)(6) 2011, SCAR TISSUE FROM BARD VENTRALEX SURGICAL PATCH AND SURGICAL PATCH REMOVED. EVENT ABATED AFTER USE STOPPED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTRALEX 6.4CM X 6.4CM HERNIA PATCH FTL BARD 0010302 43BPD399

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| L| S