BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAYFIELD SKULL CLAMP

    MDR report key: 164017 · Received April 21, 1998

    Report

    Report Number
    1525725-1996-00007
    Event Type
    Other
    Date Received
    April 21, 1998
    Date of Event
    June 7, 1996
    Report Date
    April 15, 1998
    Manufacturer
    OHIO MEDICAL INSTRUMENT
    Product Code
    HBL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    06/10/1996 A CALL WAS REC'D STATING, AFTER RE-APPLICATION OF THE SKULL CLAMP USING CODMAN ADULT PINS THE UNIT SLIPPED A SECOND TIME. THE PT REC'D A 2 1/2 INCH LACERATION ON THE LEFT SIDE OF THE HEAD, SUTURES WERE REQUIRED. THE FIRST TIME CHILD DISPOSABLE PINS WERE BEING USED AND THERE, WAS A 1-1/2 INCH LACERATION ON THE LEFT SIDE OF THE PT'S 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 941

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other