BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOLSCULPTING

    MDR report key: 15265776 · Received August 19, 2022

    Report

    Report Number
    MW5111621
    Event Type
    Injury
    Date Received
    August 19, 2022
    Date of Event
    January 5, 2022
    Report Date
    August 18, 2022
    Manufacturer
    ALLERGAN/ ABBVIE IRELAND NL B.V. BALLYTIVNAN
    Product Code
    OOK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    PARADOXAL ADIPOSE HYPERPLASIA (PAH) FROM COOLSCULPTING. FDA SAFETY REPORT ID #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381501 COOLSCULPTING DERMAL COOLING PACK/VACUUM/MASSAGER OOK ALLERGAN/ ABBVIE IRELAND NL B.V. BALLYTIVNAN

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Other CURRENT PRESCRIPTION MEDICATIONS: LEXAPRO.