BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOLSCULPTING® SYSTEM

    MDR report key: 16640528 · Received March 29, 2023

    Report

    Report Number
    3007215625-2023-00405
    Event Type
    Injury
    Date Received
    March 29, 2023
    Date of Event
    March 14, 2023
    Report Date
    August 15, 2023
    Manufacturer
    ALLERGAN PLEASANTON
    Product Code
    OOK
    PMA / PMN Number
    K160259
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION (PROVIDED FROM CEF RECEIVED AFTER THE INITIAL EMDR): A2 (DOB), A3 (GENDER), A4 (WEIGHT), A4 (WEIGHT UNITS), A6 (RACE), D1 (BRAND NAME), CONCOMITANT PRODUCT (TWO APPLICATORS), AND B5 (COMPLAINT DESCRIPTION).

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE COOLSCULPTING USER MANUAL, UNDER RARE ADVERSE EVENTS, PARADOXICAL ADIPOSE HYPERPLASIA (PH/PAH) 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. PAH IS NOT RELATED TO ANY COOLSCULPTING DEVICE FAILURE MODE BUT IT IS INCLUDED IN THE RISK MANAGEMENT FILES OF THE DEVICE BECAUSE IT IS A RISK THAT IS INHERENT TO THE USE CRYOLIPOLYSIS FOR LOCALIZED FAT REDUCTION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF AND WHEN ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 0

    ALLERGAN AESTHETICS RECEIVED A REPORT OF A PATIENT TREATED WITH COOLSCULPTING TO THE INFRA-SCAPULAR AREA ON (B)(6) 2022 USING THE COOLADVANTAGE+ COOLCURVE AND DEVELOPED PARADOXICAL HYPERPLASIA (PAH/PH) THREE MONTHS AFTER TREATMENT. DIAGNOSED ON (B)(6) 2023 WITH PARADOXICAL ADIPOSE HYPERPLASIA (PAH) BY MEDICAL PROFESSIONAL.

    Description of Event or Problem · 0

    ALLERGAN AESTHETICS RECEIVED A REPORT THAT A PATIENT RECEIVED A COOLSCULPTING TREATMENT AND PRESENTED WITH PARADOXICAL HYPERPLASIA (PAH/PH).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571675 COOLSCULPTING® SYSTEM DERMAL COOLING PACK/VACUUM/MASSAGER OOK ALLERGAN PLEASANTON NI

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Female Required Intervention 2014316003| 2014318006