BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOLSCULPTING® SYSTEM

    MDR report key: 17716871 · Received September 9, 2023

    Report

    Report Number
    3007215625-2023-01392
    Event Type
    Injury
    Date Received
    September 9, 2023
    Date of Event
    August 25, 2023
    Report Date
    October 26, 2023
    Manufacturer
    ALLERGAN PLEASANTON
    Product Code
    OOK
    PMA / PMN Number
    -
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: A2, A3, A4, B5, D1, D4, AND E1.

    Additional Manufacturer Narrative · 0

    THIS 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

    ALLERGAN AESTHETICS RECEIVED A REPORT OF A PATIENT WHO RECEIVED COOLSCULPTING TREATMENT AND MAY HAVE DEVELOPED PARADOXICAL HYPERPLASIA (PH). THE CEF FORM AND REQUEST FOR ADDITIONAL INFORMATION WAS SENT TO THE PROVIDER TO DOCUMENT THE DEVICE INFORMATION, DETAILS ON TREATED AREA, AND TREATMENT DATE SINCE THE INFORMATION WAS NOT PROVIDED AT FIRST CONTACT.

    Description of Event or Problem · 0

    ALLERGAN AESTHETICS RECEIVED A REPORT THAT A PATIENT RECEIVED A COOLSCULPTING TREATMENT TO THE FULL ABDOMEN ON (B)(6) 2022 AND (B)(6) 2022 USING A COOLADVANTAGE APPLICATOR AND PRESENTED WITH PARADOXICAL HYPERPLASIA (PAH/PH).

    Description of Event or Problem · 0

    ALLERGAN AESTHETICS RECEIVED A REPORT OF A PATIENT WHO RECEIVED COOLSCULPTING TREATMENT AND MAY HAVE DEVELOPED PARADOXICAL HYPERPLASIA (PH). THE CEF FORM AND REQUEST FOR ADDITIONAL INFORMATION WAS SENT TO THE PROVIDER TO DOCUMENT THE DEVICE INFORMATION, DETAILS ON TREATED AREA, AND TREATMENT DATE SINCE THE INFORMATION WAS NOT PROVIDED AT FIRST CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614928 COOLSCULPTING® SYSTEM DERMAL COOLING PACK/VACUUM/MASSAGER OOK ALLERGAN PLEASANTON NI

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Female Required Intervention