BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 843484 · Received April 27, 2007

    Report

    Report Number
    2523209-2007-00001
    Event Type
    Injury
    Date Received
    April 27, 2007
    Report Date
    April 24, 2007
    Manufacturer
    CUSTOM ULTRASONICS, INC.
    Product Code
    FEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    CU HAS CROSS-CHECKED THE ALLEGATION OF A "POSSIBLE CHEMICAL BURN" AGAINST ITS COMPLAINT FILES AND HAS FOUND NO PRIOR INSTANCES OF THE REPORTED PROBLEM.

    Description of Event or Problem · 1

    CUSTOM ULTRASONICS (CU) HAS BEEN NOTIFIED OF REPORT OF A "POSSIBLE CHEMICAL BURN" THAT OCCURRED MORE THAN THREE YEARS AGO. UNFORTUNATELY, THIS REPORT DOES NOT PROVIDE ANY MEANS FOR CU TO CONTACT THE REPORTER OR FACILITY TO FOLLOW-UP AND CONFIRM THIS REPORT. WITHOUT THE ABILITY TO FOLLOW-UP, CU IS NOT SURE IF THIS INFO REASONABLY SUGGESTS THAT A SERIOUS INJURY OR DEVICE MALFUNCTION ACTUALLY OCCURRED. NONETHELESS, WE ARE REPORTING THIS INCIDENT OUT OF AN ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * ULTRASONIC MEDICAL EQUIPMENT CLEANER FEB CUSTOM ULTRASONICS, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other