BEUDAMED
    FDA Adverse Event Other Summary report: N

    ZERONA

    MDR report key: 1621614 · Received February 25, 2010

    Report

    Report Number
    MW5014950
    Event Type
    Other
    Date Received
    February 25, 2010
    Date of Event
    February 1, 2010
    Report Date
    February 25, 2010
    Manufacturer
    ERCHONICA MEDICAL
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RECEIVED 6 TREATMENTS WITH ZERONA LASER FROM (B) (6) IN (B) (6). (B) (6) TOLD ME I WAS AN "EXCELLENT CANDIDATE" FOR THE TREATMENT, AND ADVISED THAT THEY HAD NEVER HAD A PT WHO HADN'T LOST AT LEAST 3 INCHES WITH ZERONA. AT THE END OF TREATMENT, I HAD NO RESULTS WHATSOEVER, AT WHICH POINT (B) (6) SUGGESTED ALTERNATIVE, MORE EXPENSIVE TREATMENTS. HAVE SINCE DISCOVERED, FROM CONSULTING WITH OTHER ZERONA PROVIDERS, THAT (B) (6) DID NOT OPERATE THE ZERONA MACHINE PROPERLY; THEY DO NOT MEASURE THE DISTANCE IT WAS PLACED FROM MY BODY, AND DID NOT POSITION IT PROPERLY, SINCE I WAS ABLE TO SEE THE LASER MOVING ON THE WALL NEXT TO ME - LASERS SHOULD HAVE BEEN POINTED AT MY BODY. ALSO, ACCORDING TO MFR'S PROTOCOL, MY MEASUREMENTS SHOULD HAVE BEEN TAKEN PRE-TREATMENT IN 10 DIFFERENT PLACES ON MY BODY. (B) (6) TOOK ONLY 4 MEASUREMENTS PRE-TREATMENT, AND INITIALLY TRIED TO MEASURE OVER MY CLOTHES. FORTUNATELY, I HAVE SUFFERED NO ADVERSE PHYSICAL EFFECTS, BUT I HAVE PAID (B) (6) FOR NOTHING. (B) (6). DOSE OR AMOUNT: 40 MINUTES, FREQUENCY: 6 TREATMENTS, ROUTE: OTHER. DATES OF USE: (B) (6) 2010 - (B) (6) 2010. DIAGNOSIS OR REASON FOR USE: ADVERTISING PROMISES FAT LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZERONA ZERONA GEX ERCHONICA MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other