BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KONA

    MDR report key: 2841907 · Received November 14, 2012

    Report

    Report Number
    9616256-2012-00001
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    October 8, 2012
    Report Date
    November 14, 2012
    Manufacturer
    RADIANCY LTD.
    Product Code
    GEX
    PMA / PMN Number
    K072331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS CONFIRMED VIA PHONE ON (B)(4) 2012 WITH THE KONA PROVIDER THAT THE AREA SUSTAINING BURNS WAS FIRST PREPPED WITH ALCOHOL. THE USER MANUAL FOR THE KONA SPECIFICALLY WARNS AGAINST USING THE KONA AFTER TREATING SKIN WITH ALCOHOL. RADIANCY PERSONNEL DISCUSSED THE BURN DESCRIPTION WITH THE KONA PROVIDER, AND DISAGREE THAT THE BURN WOULD BE DIAGNOSED 3RD DEGREE BASED ON THE DESCRIPTION (IN ADDITION, 3RD DEGREE BURNS ARE HIGHLY UNLIKELY WITH A DEVICE OF THIS TYPE, EVEN IN THE PRESENCE OF ALCOHOL). IN ADDITION, DURING CUSTOMER TRAINING (PROVIDED ON (B)(4) 2012), RADIANCY REPRESENTATIVES SPECIFICALLY WARNED AGAINST PREPARING THE SKIN WITH ALCOHOL PRIOR TO TREATMENT, AS IT CAN INTENSIFY THE AFFECTS OF A NORMAL ERYTHEMA-LIKE REACTION TO THE TREATMENT. IN THIS CASE, THE PROVIDER ACKNOWLEDGED THAT THE SKIN WAS PREPARED WITH ALCOHOL PRIOR TO TREATMENT. RADIANCY BELIEVE THE DEVICE MALFUNCTIONED.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PATIENT, WITH FITZPATRICK SKIN TYPE 3, RECEIVED HAIR REDUCTION TREATMENT ON THE LEGS FROM A KONA PROVIDER. TWO DAYS LATER THE PATIENT COMPLAINED HER LEGS WERE STILL BURNING AND THEN WENT TO HER DERMATOLOGIST. THE DERMATOLOGIST (FROM WHAT WAS RELAYED TO THE KONA PROVIDER) STATED THE PATIENT HAS 2ND AND 3RD DEGREE BURNS ON HER LEGS AND PRESCRIBED TREATMENT. THE KONA PROVIDER SAW PICTURES AND SAID THERE WERE BLISTERS ON THE PATIENTS LEGS, AND NOTIFIED RADIANCY ON (B)(6) 2012. THE PROVIDER CONFIRMED THAT TEST DOSES WERE COMPLETED ON THE PATIENTS SKIN WHICH DID NOT BURN THE PATIENT. THE PROVIDER ALSO NOTED THAT THE BURNS SEEMED TO BE WORSE ON THE AREAS THAT WERE TREATED LAST. SHE STATED THE PATIENT WAS TREATED AT THE SETTING OF 35.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KONA PULSED LIGHT SYSTEM GEX RADIANCY LTD. 3009900 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Other SKIN PREPARED WITH ALCOHOL PRIOR TO TREATMENT.