BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIDAS REX I MO

    MDR report key: 416113 · Received September 6, 2002

    Report

    Report Number
    1625507-2002-00089
    Event Type
    Malfunction
    Date Received
    September 6, 2002
    Report Date
    August 6, 2002
    Manufacturer
    MEDTRONIC MIDAS REX
    Product Code
    HBB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    "LEAKS" WAS REPORTED ON CUSTOMER REPAIR PAPERWORK. NO PATIENT INJURY OR DELAY IN SURGERY WAS REPORTED, BUT NO ADDITIONAL INFORMATION COULD BE OBTAINED ON FOLLOW UP WITH THE HOSPITAL PERSONNEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIDAS REX I MO PNEUMATIC SURGICAL DRILL, MIDAS HBB MEDTRONIC MIDAS REX NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO