BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOLSCULPTING ELITE SYSTEM

    MDR report key: 16823891 · Received April 27, 2023

    Report

    Report Number
    3007215625-2023-00539
    Event Type
    Injury
    Date Received
    April 27, 2023
    Date of Event
    November 15, 2022
    Report Date
    January 15, 2025
    Manufacturer
    ALLERGAN PLEASANTON
    Product Code
    OOK
    PMA / PMN Number
    K183514
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION.

    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.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: D1. THE CORRECT DATE RECEIVED BY MANUFACTURING DATE OF THE PREVIOUSLY SUBMITTED MEDWATCH REPORT 3007215625-2023-00539 FOLLOW-UP 1 IS (B)(6) 2023.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE PROVIDER THAT THE AREA PRESENTING PARADOXICAL HYPERPLASIA (PAH/PH) IS THE BILATERAL FLANKS.

    Description of Event or Problem · 0

    ALLERGAN AESTHETICS RECEIVED A REPORT THAT A PATIENT RECEIVED A COOLSCULPTING TREATMENT TO THE BRA ROLL/ BACK FAT, MID ABDOMEN, FLANKS ON (B)(6) 2022 AND (B)(6) 2022 USING THE C150 APPLICATOR AND PRESENTED WITH PARADOXICAL HYPERPLASIA (PAH/PH) TO THE BACK FAT/BRA ROLL AREA.

    Description of Event or Problem · 0

    ALLERGAN AESTHETICS RECEIVED A REPORT THAT A PATIENT RECEIVED A COOLSCULPTING TREATMENT TO THE BRA ROLL/ BACK FAT, MID ABDOMEN, FLANKS ON (B)(6) 2022 USING THE C150 APPLICATOR AND PRESENTED WITH PARADOXICAL HYPERPLASIA (PAH/PH) TO THE BILATERAL FLANKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1461704 COOLSCULPTING ELITE SYSTEM DERMAL COOLING PACK/VACUUM/MASSAGER OOK ALLERGAN PLEASANTON NI

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Required Intervention