BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOLSCULPTING SYSTEM

    MDR report key: 13358433 · Received January 26, 2022

    Report

    Report Number
    3007215625-2022-00152
    Event Type
    Injury
    Date Received
    January 26, 2022
    Date of Event
    January 4, 2022
    Report Date
    August 16, 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

    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

    DISREGARD NON-REPORTABLE EVENT CODES OF E2338 SWELLING/ EDEMA, E1714 RASH, E1716 SKIN DISCOLORATION, AND E013403 PARESTHESIA.

    Description of Event or Problem · 0

    ALLERGAN AESTHETICS RECEIVED A REPORT OF A PATIENT WHO WAS TREATED WITH COOLSCULPTING TO THE SUBMENTAL AREA AND MAY HAVE DEVELOPED PARADOXICAL HYPERPLASIA ALONG WITH DISCOLORATION AND TINGLING. PATIENT ALSO REPORTED RASH AND SWELLING IN TREATMENT AREA.

    Description of Event or Problem · 0

    ALLERGAN AESTHETICS RECEIVED A REPORT OF A PATIENT TREATED WITH COOLSCULPTING TO THE SUBMENTAL AREA ON (B)(6) 2021 USING THE COOLADVANTAGE COOLMINI SYSTEM APPLICATORS, WHO MAY HAVE DEVELOPED PARADOXICAL HYPERPLASIA (PH) AFTER TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830889 COOLSCULPTING SYSTEM DERMAL COOLING PACK/VACUUM/MASSAGER OOK ALLERGAN PLEASANTON NI

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Female Required Intervention