BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KOMET MEDICAL

    MDR report key: 187032 · Received September 11, 1998

    Report

    Report Number
    187032
    Event Type
    Malfunction
    Date Received
    September 11, 1998
    Date of Event
    August 21, 1998
    Report Date
    September 9, 1998
    Manufacturer
    KOMET MEDICAL
    Product Code
    HWE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    METAL CUTTING WHEEL KM-M51U, LOT # KM702 1102, MADE BY KOMET MEDICAL AS A REPLACEMENT FOR MIDAS REX PRODUCT M-51 WAS NOT LONG ENOUGH TO SEAT PROPERLY AND TIGHTEN INTO POWER HANDPIECE OF MIDAS REX DRILL. CO REP REPORTEDLY STATES THAT LOT # ABOVE IS SHORTER THAN SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KOMET MEDICAL METAL CUTTING WHEEL HWE KOMET MEDICAL KM-M51U KM 7021102

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other