BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOLADVANTAGE APPLICATOR

    MDR report key: 11767753 · Received May 3, 2021

    Report

    Report Number
    3007215625-2021-01242
    Event Type
    Injury
    Date Received
    May 3, 2021
    Date of Event
    October 8, 2020
    Report Date
    May 3, 2021
    Manufacturer
    ZELTIQ AESTHETICS, INC.
    Product Code
    OOK
    PMA / PMN Number
    K160259
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING INFORMATION IS IN THE COOLSCULPTING USER MANUAL: PARADOXICAL 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. INVESTIGATION STILL PENDING RESPONSE FROM TREATMENT PROVIDER.

    Description of Event or Problem · 1

    A TREATMENT PROVIDER REPORTED A PATIENT WHO WAS TREATED WITH COOLSCULPTING TO THE ABDOMEN AND ARMS ON (B)(6) 2020 AND TO THE INNER THIGHS ON (B)(6) 2020. A FEW MONTHS POST TREATMENT, THE PATIENT PRESENTED WITH PARADOXICAL HYPERPLASIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655844 COOLADVANTAGE APPLICATOR DERMAL COOLING PACK/VACUUM/MASSAGER OOK ZELTIQ AESTHETICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other