BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOLSCULPTING

    MDR report key: 14946781 · Received July 6, 2022

    Report

    Report Number
    MW5110728
    Event Type
    Injury
    Date Received
    July 6, 2022
    Date of Event
    October 22, 2021
    Report Date
    July 4, 2022
    Manufacturer
    ALLERGAN ABBVIE IRELAND NL B.V. BALLYTIVNAN
    Product Code
    OOK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    DEVELOPED PARADOXICAL ADIPOSE HYPERPLASIA FROM COOLSCULPTING. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1986140 COOLSCULPTING DERMAL COOLING PACK/VACUUM/MASSAGER OOK ALLERGAN ABBVIE IRELAND NL B.V. BALLYTIVNAN

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Other