BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VECTRA GENISYS LASER

    MDR report key: 1404660 · Received June 5, 2009

    Report

    Report Number
    1022819-2009-00144
    Event Type
    Injury
    Date Received
    June 5, 2009
    Date of Event
    April 1, 2009
    Report Date
    May 12, 2009
    Manufacturer
    CHATTANOOGA GROUP
    Product Code
    ILY
    PMA / PMN Number
    040662
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE EVAL WAS PERFORMED BY OUR ENGINEERING DEPARTMENT. ROOT CAUSE IS UNK BECAUSE THE DEVICE PERFORMED TO SPECIFICATION AND TO ITS INTENDED USE. THE ENGINEERING DEPARTMENT DID NOT FIND ANY PROBLEMS WITH THE DEVICE. CONCLUSION: UNIT PASSED ALL TEST CONDUCTED, NO ANOMALIES WERE FOUND. CHECKING UNIT WITH THE LASER APPLICATOR THE UNIT AND APPLICATOR OUTPUT WAS 1.34W'S. THE UNIT MEETS ALL MANUFACTURES SPECIFICATIONS.

    Description of Event or Problem · 1

    THE PT WAS BEING TREATED WITH LASER FOR MUSCLE SPASMS AND INFLAMMATION TO THE BILATERAL TRAPS WHEN THEY RECEIVED A SKIN BLISTER. THE DOSAGE WAS SET TO 7.5 J-CM SQUARED FOR 1.44 MINUTES OF TREATMENT. THERE WAS NO PROTECTIVE BARRIER BETWEEN THE SKIN AND THE APPLICATION. THE APPLICATOR WAS SLIGHTLY ABOVE AND IN SOME CASES TOUCHING THE SKIN. DURING THE TREATMENT, THE PT DID COMPLAIN THAT THE APPLICATOR WAS HOT AT TIMES. AFTER THE TREATMENT, SEVERAL BLISTERS OCCURRED ON BOTH SIDES OF THE TRAPS. THE BLISTERS WERE LESS THAN AN INCH IN SIZE. THE PT DID NOT SEEK MEDICAL ATTENTION OR MEDICATION FOR THE INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VECTRA GENISYS LASER ILY CHATTANOOGA GROUP 2784

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other