BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONY XL LP YAG HANDPIECE

    MDR report key: 3011235 · Received March 18, 2013

    Report

    Report Number
    3004167969-2013-00001
    Event Type
    Injury
    Date Received
    March 18, 2013
    Date of Event
    January 29, 2013
    Report Date
    March 15, 2013
    Manufacturer
    ALMA LASERS LTD.
    Product Code
    GEX
    PMA / PMN Number
    K72564
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT HAD RECEIVED AESTHETIC LASER TREATMENTS AT SAME FACILITY FOR 6 YEARS WITH NO PROBLEMS. LASER HANDPIECE PERFORMED WITHIN EXPECTED MANUFACTURER'S SPECIFICATIONS. NO OTHER PATIENTS TREATED WITH THIS HANDPIECE HAVE HAD ANY REPORTED EVENTS. PRACTITIONER'S REPORTED TREATMENT PARAMETERS WERE WITHIN CLINICAL GUIDELINES FOR THIS EQUIPMENT. SCARS ARE A KNOWN POTENTIAL ADVERSE EVENT OF THIS TYPE OF TREATMENT. WE COULD NOT DETERMINE WHY THIS OCCURRED ON THIS PARTICULAR PATIENT.

    Description of Event or Problem · 1

    ALMA INC. FIRST NOTIFIED OF INCIDENT ON (B)(6) 2013. THE PRACTITIONER STARTED TREATING PATIENT AT 80J AND NOTICED A SMALL BLISTER, SO THEY REDUCED THE FLUENCE AND NOTICED ANOTHER SMALL BLISTER AND ERYTHEMA. COOLING AND BACITRACIN WAS APPLIED. THE PATIENT RETURNED 2 WEEKS LATER FOR HAIR REMOVAL AND ASKED IF HER LEG (UPPER RIGHT LEG ABOVE KNEE) WAS SUPPOSED TO LOOK LIKE THIS BECAUSE SHE HAD TWO LINEAR SCABS AND REDNESS. PATIENT WAS ASKED WHY SHE DID NOT RETURN FOR A FOLLOW-UP VISIT OR CALL TO ASK ABOUT APPEARANCE OF LEG, AND PATIENT STATED SHE DIDN¿T KNOW WHAT IT WAS SUPPOSED TO LOOK LIKE. PATIENT STATED THAT A BLISTER RUPTURED, BUT NO INFECTION WAS NOTED. PATIENT CONSULTED WITH A PHYSICIAN COWORKER WHO PUT HER ON DOXYCYCLINE AND BACITRACIN. PATIENT IS FOLLOWING UP WITH THE OFFICE PHYSICIAN AND NURSE PRACTITIONER. GEL WAS USED FOR THE PROCEDURE, AND PRACTITIONER DID NOT OVERLAP. SAME PATIENT HAS BEEN TREATED FOR LEG VEINS USING THE LP YAG FOR APPROX. 6 YEARS WITH NO ADVERSE REACTIONS. PRACTITIONER STATED SHE USED THE HP ON ANOTHER PATIENT AND NOTICED A VERY SMALL BLISTER. ALMA INC. SUGGESTED SHE STOP USING THE HP AND RETURN TO ALMA INC. FOR SERVICE INSPECTION. HP WAS RETURNED TO ALMA INC. BOTH THE PREVIOUS HP AND THIS HP WERE CHECKED BY SERVICE, AND FOUND TO BE OPERATING WITHIN MANUFACTURING SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112261 HARMONY XL LP YAG HANDPIECE MEDICAL LASER GEX ALMA LASERS LTD. LP YAG NA

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention VITAMINS| CALCIUM SUPPLEMENTS