BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRAWBERRY LIFT

    MDR report key: 10697884 · Received October 16, 2020

    Report

    Report Number
    MW5097301
    Event Type
    Injury
    Date Received
    October 16, 2020
    Date of Event
    October 13, 2020
    Report Date
    October 14, 2020
    Manufacturer
    LASER LIPO LIMITED
    Product Code
    OLI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I WAS BURNED; I RECEIVED A STRAWBERRY LASER CHIN LIFT TREATMENT FROM (B)(6) WEIGHT CONTROL IN (B)(6). MY JAW MUSCLES WERE SO CONTRACTED AND THE PROCEDURE WAS SO PAINFUL. THE WAND USED OVER MY CHIN FELT LIKE IT SHOCKED MY NERVE ENDINGS. I WAS TOLD THIS WAS NORMAL WITH PEOPLE WHO HAVE FILLINGS OR DENTAL WORK. WHEN I LOOKED UP THE MACHINE ON THE STRAWBERRY-LASER.COM WEBSITE IT SAYS IT IS NOT FDA APPROVED. THIS MACHINE HAS A WAND WHICH THEY CALL A SPOT REDUCTION PROBE. THEY DO NOT SAY WHAT THE TECHNOLOGY IS WHEN I ASK THEM. THEY SAY IT'S PATENTED. I BELIEVE IT IS HIFU BECAUSE THE MACHINE SAYS SHOTS AND WHEN I (B)(6) IT THIS IS NOT AN FDA APPROVED PROCEDURE. I SPOKE TO MY SISTER IN LAW WHO OWNS A SPA AND SHE SAID SHOTS ARE DEFINITELY HIFU OR IPL. WHAT'S STRANGE IS ON THEIR WEBSITE IT SHOWS A PICTURE OF THE LIFT SYSTEM THAT WAS USED ON ME, BUT THEY ARE CLAIMING IT'S AN INCH LOSS MACHINE. I'VE ATTACHED THE PICTURE OF THE DEVICE THAT WAS USED ON ME. IT IS DEFINITELY THE CHIN MACHINE. I HAVE BEEN A STRAWBERRY INCH LOSS CLIENT BEFORE AND THIS IS NOT THE MACHINE I WAS TREATED WITH BEFORE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1155931 STRAWBERRY LIFT FAT REDUCING LOW LEVEL LASER OLI LASER LIPO LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 Other