BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASSY, HEADBAND ULTRALITE 2 BIF

    MDR report key: 3181322 · Received June 14, 2013

    Report

    Report Number
    1222895-2013-00013
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    May 28, 2013
    Report Date
    June 14, 2013
    Manufacturer
    INTEGRA BURLINGTON, MA, INC.
    Product Code
    FCW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    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

    A REPORT WAS RECEIVED THAT DURING SURGERY, A SURGEON FELT THAT THE HEADLIGHT WAS WARM, AND THEN SMELLED SOMETHING BURNING. WHEN SURGERY WAS COMPLETE, AND THE SURGEON (PLASTIC SURGEON) LEFT THE THEATRE, HE TOOK OFF THE HEADLIGHT AND SAW IT HAD MELTED AWAY AT THE BACK, AND THAT IS WHEN HE NOTED THAT HE HAD A SMALL BLISTER OR FULL THICKNESS INJURY ON BRIDGE OF HIS NOSE. THE SURGEON TREATED HIMSELF, AND THERE ARE NO FURTHER ISSUES. HOSPITAL REPORTED BOTH LUXTEC CABLES AND LUXTEC LIGHTSOURCE USED WITH THIS HEADLIGHT. BIOMED STATED THERE WAS NO EFFECT ON PATIENT BEING OPERATED ON, AND THAT SURGERY FOR PATIENT PROCEED AS NORMALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271901 ASSY, HEADBAND ULTRALITE 2 BIF NA FCW INTEGRA BURLINGTON, MA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1