BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HALO

    MDR report key: 2720773 · Received August 27, 2012

    Report

    Report Number
    MW5026699
    Event Type
    Malfunction
    Date Received
    August 27, 2012
    Date of Event
    August 6, 2012
    Report Date
    August 10, 2012
    Manufacturer
    CORE LABS, LLC
    Product Code
    IYB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    UNWANTED CORROSION APPEARED ON THE DEVICE, WHICH MAY CAUSE (CAUSED) STRUCTURAL DAMAGE TO THE UNIT. FURTHER INVESTIGATION IS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HALO OVERHEAD TUBE HOLDER IYB CORE LABS, LLC 02-000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other