BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOLSCLUPTING

    MDR report key: 14946469 · Received July 6, 2022

    Report

    Report Number
    MW5110720
    Event Type
    Injury
    Date Received
    July 6, 2022
    Date of Event
    March 21, 2021
    Report Date
    July 3, 2022
    Manufacturer
    ABBVIE IRELAND NL B.V. BALLYTIVNAN
    Product Code
    OOK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ME, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    GOT PAH (PAH (PARADOXICAL ADIPOSE HYPERPLASIA)) FROM COOLSCLUPTING DEVICE. HAVE TERRIBLE SIDE EFFECTS FROM COOLSCLUPTING. BIG PAINFUL BULDGES ON MY FLANKS AND ABDOMEN. "ALLEGAN/ABBIE". FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1986126 COOLSCLUPTING DERMAL COOLING PACK/VACUUM/MASSAGER OOK ABBVIE IRELAND NL B.V. BALLYTIVNAN

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Required Intervention| O CALCIUM| LIPITOR 10MG| VIT B-12| VIT D