BEUDAMED
    FDA Adverse Event Summary report: N

    MAYFIELD MODIFIED SKULL CLAMP

    MDR report key: 1102484 · Received August 5, 2008

    Report

    Report Number
    3004608878-2008-00061
    Date Received
    August 5, 2008
    Report Date
    August 5, 2008
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    HBL
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THERE WAS A PT LACERATION. WAS TOLD BY THE CONTACT, THAT THE PT WAS IN THE PRONE POSITION WHEN THE DEVICE SLIPPED. THE PT SUSTAINED A LACERATION. ADD'L INFO FROM THE FACILITY HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAYFIELD MODIFIED SKULL CLAMP NONE HBL INTEGRA LIFESCIENCES CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1