BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL DRILL

    MDR report key: 1712985 · Received August 31, 2009

    Report

    Report Number
    1811755-2009-00463
    Event Type
    Malfunction
    Date Received
    August 31, 2009
    Date of Event
    December 4, 2007
    Report Date
    December 10, 2007
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF 08/21/2009, THE HANDPIECE HAS NOT BEEN RETURNED FOR EVAL. NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP THAT THE HANDPIECE HEATED UP AND THE PT RECEIVED A SUPERFICIAL BURN. NO FURTHER INFO HAS BEEN RECEIVED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIVERSAL DRILL BONE CUTTING INSTRUMENTS AND ACCESSORIES ERL STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK