BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOLSCULPTING® ELITE SYSTEM

    MDR report key: 17506094 · Received August 10, 2023

    Report

    Report Number
    3007215625-2023-01165
    Event Type
    Injury
    Date Received
    August 10, 2023
    Date of Event
    May 15, 2023
    Report Date
    September 28, 2023
    Manufacturer
    ALLERGAN PLEASANTON
    Product Code
    OOK
    PMA / PMN Number
    K183514
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: A4 B3 D3 D8 D10 H3.

    Additional Manufacturer Narrative · 0

    THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN PRODUCT LABELING. 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 ELITE ON (B)(6) 2021 (PER CEF) TO THE SUBMENTAL USING CURVE 80 APPLICATOR AND THE INFRA-SCAPULAR AREA USING THE CURVE 150 APPLICATOR AND DEVELOPED PARADOXICAL HYPERPLASIA (PAH/PH) FIVE 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 OF A PATIENT TREATED WITH COOLSCULPTING ELITE ON (B)(6) 2021 (PER CEF) TO THE SUBMENTAL USING CURVE 80 APPLICATOR AND THE INFRA-SCAPULAR AREA USING THE CURVE 150 APPLICATOR AND DEVELOPED PARADOXICAL HYPERPLASIA (PAH/PH) FIVE MONTHS AFTER TREATMENT. DIAGNOSED ON (B)(6) 2023 WITH PARADOXICAL ADIPOSE HYPERPLASIA (PAH) BY MEDICAL PROFESSIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1353972 COOLSCULPTING® ELITE SYSTEM DERMAL COOLING PACK/VACUUM/MASSAGER OOK ALLERGAN PLEASANTON NI

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Required Intervention C150 APPLICATOR SN: (B)(6).| C80 APPLICATOR SN:(B)(6).| CS4M2015301001.