BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HITH KIT

    MDR report key: 2003566 · Received February 22, 2011

    Report

    Report Number
    1722447-2011-00004
    Event Type
    Injury
    Date Received
    February 22, 2011
    Report Date
    June 14, 2011
    Manufacturer
    INTEGRA PAIN MANAGEMENT
    Product Code
    HBF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT EXPECTED TO BE RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DRILL BITS WERE TOO AGGRESSIVE AND HAD CAUSED SOME ADDED HEAD TRAUMA TO THE PATIENT WHEN PLACING THE BURR HOLES. ADDITIONAL CLINICAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HITH KIT NA HBF INTEGRA PAIN MANAGEMENT

    Patients

    Seq Age Sex Outcome Treatment
    1