BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VELASHAPE

    MDR report key: 2765648 · Received September 25, 2012

    Report

    Report Number
    MW5027052
    Event Type
    Injury
    Date Received
    September 25, 2012
    Report Date
    September 15, 2012
    Product Code
    NUV
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    AFTER 1 VELASHAPE TREATMENT, HAD GURGLING WHOOSH IN MY ABDOMEN THAT NIGHT, FELT FINE OTHERWISE. AFTER 2ND VISIT, I BEGAN PUTTING WEIGHT ON IN MY ABDOMEN. THINKING IT WAS JUST A FLUKE CHANGE, I WENT TO MY THIRD VISIT. AGAIN, I PUT ON WEIGHT. CONCERNED, I MET WITH STAFF BEFORE FINAL TREATMENT. WAS TOLD THAT I WAS PROBABLY SLUGGISH IN MY GI TRACT AND IT IS UNRELATED EXCEPT THAT THE TREATMENT WAS PROBABLY ELIMINATING FASTER THAN MY BODY WAS. IT WAS SUGGESTED THAT I GO AHEAD WITH MY 4TH AND FINAL TREATMENT. I DID. I'M BIGGER THAN EVER AND VERY CONCERNED. DATES OF USE: (B)(6) 2012. REASON FOR USE: COULDN'T GET RID OF FAT POUCH AFTER BABIES. EVENT REAPPEARED AFTER REINTRODUCTION: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VELASHAPE VELASHAPE NUV

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other