BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOL SCULPTING SYSTEM

    MDR report key: 6085265 · Received November 7, 2016

    Report

    Report Number
    MW5065863
    Event Type
    Injury
    Date Received
    November 7, 2016
    Date of Event
    May 15, 2016
    Report Date
    November 7, 2016
    Manufacturer
    ZELTIQ AESTHETICS INC.
    Product Code
    OOK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER CALLED FROM (B)(6) AND STATED THAT SHE HAD A FAT REDUCTION PROCEDURE DONE AROUND HER WAIST AREA IN (B)(6) 2016. THIS PROCEDURE WAS SUPPOSE TO MAKE THE AREA REDUCE BY TWENTY TO TWENTY FIVE PERCENT BUT INSTEAD, IT HAS INCREASED BY TWENTY FIVE PERCENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733256 COOL SCULPTING SYSTEM DERMAL COOLING PACK/VACUUM/MASSAGER OOK ZELTIQ AESTHETICS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR