BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK COOLSCULPTING

    MDR report key: 14214950 · Received April 26, 2022

    Report

    Report Number
    3007215625-2022-00624
    Event Type
    Injury
    Date Received
    April 26, 2022
    Date of Event
    April 5, 2022
    Report Date
    April 26, 2022
    Manufacturer
    ALLERGAN PLEASANTON
    Product Code
    OOK
    PMA / PMN Number
    K160259
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    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: H11: SUBSEQUENT TO THE SUBMISSION OF INITIAL MDR, IT WAS NOTED THAT THE EVENT WAS POST INFLAMMATORY HYPERPIGMENTATION (PIH) AS OPPOSED TO PARADOXICAL ADIPOSE HYPERPLASIA (PAH); THEREFORE, THIS EVENT IS CONSIDERED NOT REPORTABLE.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    A TREATMENT PROVIDER REPORTED THAT A PATIENT TREATED ON THE FLANK WITH COOLSCULPTING ON 11/18/2021 PRESENTED WITH POST INFLAMMATORY HYPERPIGMENTATION (PIH).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1494359 UNK COOLSCULPTING DERMAL COOLING PACK/VACUUM/MASSAGER OOK ALLERGAN PLEASANTON NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention