BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8FT PROXENON HEADLIGHT FIBER

    MDR report key: 2492234 · Received March 12, 2012

    Report

    Report Number
    1222895-2012-00006
    Event Type
    Injury
    Date Received
    March 12, 2012
    Date of Event
    March 2, 2012
    Report Date
    March 12, 2012
    Manufacturer
    INTEGRA BURLINGTON, MA, INC.
    Product Code
    FST
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    "THE CABLE GETS EXCESSIVELY HOT WHEN REMOVED FROM THE LIGHT SOURCE." ON (B)(6) 2012, IN DIRECT CONVERSATION WITH THE REPORTING PHYSICIAN, HE STATED: "THE CABLE WAS EXCESSIVELY HOT AND WAS SMOKING. A DIFFERENT PHYSICIAN PULLED THE CABLE OUT AND IT ACCIDENTALLY HIT HIM (THE OTHER DOCTOR) IN THE FOREHEAD CAUSING A FIRST DEGREE BURN." NO TREATMENT WAS PROVIDED AND THE BURN HAS SINCE HEALED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8FT PROXENON HEADLIGHT FIBER PROXENON HL FST INTEGRA BURLINGTON, MA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1