BEUDAMED
    FDA Adverse Event Summary report: N

    MAYFIELD SKULL CLAMP

    MDR report key: 1230133 · Received November 7, 2008

    Report

    Report Number
    3004608878-2008-00098
    Date Received
    November 7, 2008
    Date of Event
    November 3, 2008
    Report Date
    November 7, 2008
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    HBL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THERE WAS A PATIENT INJURY. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED FROM THE FACILITY. THE RESIDENT POSITIONED THE PATIENT AND ATTACHED THE SKULL CLAMP. THE ATTENDING PHYSICIAN INSPECTED IT, AND THE PRESSURE APPARENTLY APPEARED TO BE ADEQUATE. THE PATIENT WAS RE-POSITIONED TO A PRONE POSITION AND THE HEAD MOVED. THE PATIENT SUSTAINED A GASH ON THE HEAD. ADDITIONAL INFORMATION WAS REQUESTED FROM THE FACILITY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1