BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAYFIELD MODIFIED SKULL CLAMP

    MDR report key: 897297 · Received August 10, 2007

    Report

    Report Number
    3004608878-2007-00015
    Event Type
    Injury
    Date Received
    August 10, 2007
    Report Date
    July 12, 2007
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    HBL
    Report Source
    Manufacturer report
    Reporter Location
    NY, US

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INCIDENT. CORRESPONDENCE SHOULD BE SENT TO: INTEGRA LIFESCIENCES CORP. LID OR THAT THE DEVICE CAUSED OR CONTRIBUTED IN ANY WAY TO A DEATH OR SERIOUS INJURY. SEE SCANNED PAGES.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THE PT SUSTAINED A LACERATION. ADDITIONAL INFO IS BEING REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAYFIELD MODIFIED SKULL CLAMP SKULL CLAMP HBL INTEGRA LIFESCIENCES CORPORATION 001

    Patients

    Seq Age Sex Outcome Treatment
    1 YR