BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTOR, UNK

    MDR report key: 400363 · Received June 17, 2002

    Report

    Report Number
    1625507-2002-00069
    Event Type
    Injury
    Date Received
    June 17, 2002
    Date of Event
    October 16, 1998
    Report Date
    May 16, 2002
    Manufacturer
    MEDTRONIC MIDAS REX
    Product Code
    HBB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    IN 1998, WHILE PT WAS ADMITTED TO HOSP FOR SURGICAL REMOVAL OF AN ACUTE SUBDURAL HEMATOMA, THE MIDAS REX PNEUMATIC CRANIAL DRILL (USED)...CAUSED (PT) TO SUFFER SEVERE, PAINFUL, PERMANENT, DISABLING INJURIES WHEN THE MIDAS REX PNEUMATIC CRANIAL DRILL MALFUNCTIONED, CAUSING THE ATTENDING PHYSICIAN TO PERFORM AN EMERGENCY CRANIOTOMY ON THE PLAINTIFF. THE MIDAS REX DRILL WAS APPARENTLY USED WITH AN ANSPACH DRILL BIT. IT WAS REPORTED TO PUNCTURE THE DURA, CAUSING INTERNAL BLEEDING AND THE PT REQUIRED AN EMERGENCY CRANIOTOMY. THE DETAILS OF THE INJURY WERE NOT SPECIFIED. THE DRILL SERIAL NUMBER WAS UNK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention ANSPACH DRILL BIT.