BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUDDE HALO RETRACTOR

    MDR report key: 4102322 · Received August 27, 2014

    Report

    Report Number
    3004608878-2014-00154
    Event Type
    Malfunction
    Date Received
    August 27, 2014
    Report Date
    August 11, 2014
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    GZT
    PMA / PMN Number
    K830332
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THE FLEX ARM WAS FAULTY. IT WAS AN OUT OF BOX FAILURE, BRAND NEW SET NOT BEING USED ON ANYONE. THE DISTRIBUTOR TOOK IT OUT FOR INSPECTION BEFORE SENDING TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522710 BUDDE HALO RETRACTOR RETRACTOR SYSTEMS GZT INTEGRA LIFESCIENCES CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1