BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN COOLSCULPTING SYSTEM

    MDR report key: 13047718 · Received December 20, 2021

    Report

    Report Number
    3007215625-2021-02194
    Event Type
    Injury
    Date Received
    December 20, 2021
    Date of Event
    November 9, 2021
    Report Date
    June 3, 2024
    Manufacturer
    ALLERGAN PLEASANTON
    Product Code
    OOK
    PMA / PMN Number
    K160259
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H11-: CORRECTED DATA: SUBSEQUENT TO THE SUBMISSION OF INITIAL MEDWATCH, THIS REPORT HAS BEEN IDENTIFIED AS A DUPLICATE OF PREVIOUSLY SUBMITTED MEDWATCH REPORT OF 3007215625-2021-01925-00.

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE COOLSCULPTING USER MANUAL, UNDER RARE ADVERSE EVENTS, PARADOXICAL ADIPOSE HYPERPLASIA IS CHARACTERIZED BY A VISIBLY ENLARGED TISSUE VOLUME WITHIN THE TREATMENT AREA, WHICH MAY DEVELOP TWO TO FIVE MONTHS AFTER TREATMENT. SURGICAL INTERVENTION MAY BE REQUIRED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF AND WHEN ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 0

    A MEDWATCH REPORT WAS SUBMITTED TO ALLERGAN REPORTING A PATIENT WHO DEVELOPED PAH.

    Description of Event or Problem · 0

    ALLERGAN AESTHETICS RECEIVED A MEDWATCH REPORT OF A PATIENT WHO RECEIVED COOLSCULPTING TREATMENT AND PRESENTED WITH PARADOXICAL ADIPOSE HYPERPLASIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1941243 UNKNOWN COOLSCULPTING SYSTEM DERMAL COOLING PACK/VACUUM/MASSAGER OOK ALLERGAN PLEASANTON NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention