BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK COOLSCULPTING

    MDR report key: 14113478 · Received April 14, 2022

    Report

    Report Number
    3007215625-2022-00559
    Event Type
    Injury
    Date Received
    April 14, 2022
    Date of Event
    March 17, 2022
    Report Date
    April 14, 2022
    Manufacturer
    ALL
    Product Code
    OOK
    PMA / PMN Number
    K160259
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: AWARE DATE. H11: CORRECTED DATA: SUBSEQUENT TO THE SUBMISSION OF INITIAL MEDWATCH, THIS REPORT HAS BEEN IDENTIFIED AS A DUPLICATE OF PREVIOUSLY SUBMITTED MEDWATCH REPORT OF 3007215625-2022-00416-00.

    Description of Event or Problem · 0

    ALLERGAN AESTHETICS RECEIVED A REPORT OF A PATIENT TREATED WITH COOLSCULPTING DEVELOPED PARADOXICAL HYPERPLASIA (PAH/PH).

    Description of Event or Problem · 0

    UPON FURTHER REVIEW OF THE REPORTED EVENT, THIS REPORT HAS BEEN IDENTIFIED AS A DUPLICATE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1524810 UNK COOLSCULPTING DERMAL COOLING PACK/VACUUM/MASSAGER OOK ALL NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention