BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 3123891 · Received May 15, 2013

    Report

    Report Number
    2134070-2013-00105
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    April 18, 2013
    Report Date
    April 19, 2013
    Manufacturer
    STERILMED, INC.
    Product Code
    NLQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVAL, BUT WAS REPORTED TO BE HELD BY THE USER FACILITY. A SUPPLEMENTAL REPORT WILL BE SENT IF THE DEVICE IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A THYROIDECTOMY CASE BLUE CHIPS WERE FLAKING OFF THE JAWS AND INTO THE PT. THE DEVICE WAS REPORTED TO BE HELD BY THE USER FACILITY. ADDITIONAL INFO RECEIVED UPON INQUIRY REPORTED THAT WHEN THE DEVICE WAS INITIALLY USED, IT WAS NOTICED THAT THERE WAS A BLUE SUBSTANCE BEING LEFT ON THE TREATED AREAS AFTER USE. AFTER THE SECOND TIME, ANOTHER DEVICE WAS USED. THERE WAS NO PT INJURY. ADDITIONAL INFO WAS REQUESTED, BUT NO ADDITIONAL INFO WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SENT IF ADDITIONAL INFO IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215077 NA NLQ STERILMED, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR