BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN COOLSCULPTING® SYSTEM

    MDR report key: 17191147 · Received June 23, 2023

    Report

    Report Number
    3007215625-2023-00880
    Event Type
    Injury
    Date Received
    June 23, 2023
    Date of Event
    May 1, 2018
    Report Date
    June 23, 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

    ARTICLE CITATION: ATX-101 (DEOXYCHOLIC ACID INJECTION) FOR PARADOXICAL ADIPOSE HYPERPLASIA SECONDARY TO CRYOLIPOLYSIS, CHLOE E. WARD, MD (WARD 2018). PARADOXICAL ADIPOSE HYPERPLASIA IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE 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

    ACCORDING TO LITERATURE ARTICLE, "A 58-YEAR-OLD HEALTHY CAUCASIAN WOMAN PRESENTED WITH UNWANTED SUBCUTANEOUS LOWER ABDOMINAL FAT, DESPITE CONCERTED DIET CONTROL AND EXERCISE. TWO YEARS PREVIOUSLY, SHE HAD UNDERGONE LOWER ABDOMINAL COOLSCULPTING (ZELTIQ AESTHETICS, INC., PLEASANTON, CA) CRYOLIPOLYSIS TREATMENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1899840 UNKNOWN COOLSCULPTING® SYSTEM DERMAL COOLING PACK/VACUUM/MASSAGER OOK ALLERGAN PLEASANTON NI

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Required Intervention