BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAYFIELD SKULL CLAMP

    MDR report key: 164011 · Received April 21, 1998

    Report

    Report Number
    1525725-1997-00010
    Event Type
    Other
    Date Received
    April 21, 1998
    Report Date
    April 20, 1998
    Manufacturer
    OHIO MEDICAL INSTRUMENT
    Product Code
    HBL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 07/18/1997 A SKULL CLAMP WAS REC'D FOR REPAIR WITH THE COMMENT, PATIENT'S HEAD FELL OUT AND WAS LEFT WITH A LARGE CUT IN HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAYFIELD SKULL CLAMP SKULL CLAMP HBL OHIO MEDICAL INSTRUMENT 4-0-A-1059 160

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other