BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UL PRO FUSED HEADLIGHT CABLE 9FT, 275CM

    MDR report key: 2772244 · Received October 2, 2012

    Report

    Report Number
    1222895-2012-00028
    Event Type
    Malfunction
    Date Received
    October 2, 2012
    Report Date
    October 2, 2012
    Manufacturer
    INTEGRA BURLINGTON, MA, INC.
    Product Code
    LFL
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN REC'D FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE CUSTOMER INITIALLY REPORTED THAT THE NURSE EXPERIENCED 1ST DEGREE BURNS TO HER FINGER TIPS WHEN SHE UNPLUGGED THE LIGHT CABLE FROM THE MLX. THE MLX HAD OVERHEATED AND THE GREEN STRAIN RELIEF WAS EXTREMELY HOT. THERE WAS NO DELAY IN SURGERY. ON (B)(6) 2012 CUSTOMER REPORTS NO F/U ISSUES, NO TREATMENT NECESSARY FOR THE BURN (SLEE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UL PRO FUSED HEADLIGHT CABLE 9FT, 275CM CABLES LFL INTEGRA BURLINGTON, MA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 00MLX - MLX 300W XENON LIGHTSOURCE