BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN COOLSCULPTING® SYSTEM

    MDR report key: 17187995 · Received June 22, 2023

    Report

    Report Number
    3007215625-2023-00866
    Event Type
    Injury
    Date Received
    June 22, 2023
    Date of Event
    January 1, 2017
    Report Date
    October 18, 2023
    Manufacturer
    ALLERGAN PLEASANTON
    Product Code
    OOK
    PMA / PMN Number
    K160259
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HO D, JAGDEO J. A SYSTEMATIC REVIEW OF PARADOXICAL ADIPOSE HYPERPLASIA (PAH) POST-CRYOLIPOLYSIS. J DRUGS DERMATOL. 2017 JAN 1;16(1):62-67. 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.

    Additional Manufacturer Narrative · 0

    UPON FURTHER REVIEW OF THE REPORTED EVENT, IT HAS BEEN DETERMINED THAT THERE IS NO ALLEGED PARADOXICAL HYPERPLASIA (PH).

    Description of Event or Problem · 0

    ACCORDING TO LITERATURE ARTICLE, "A SYSTEMATIC REVIEW OF PARADOXICAL ADIPOSE HYPERPLASIA (PAH) POST-CRYOLIPOLYSIS" IT WAS REPORTED THAT A FEMALE PATIENT AGE 50'S WAS DIAGNOSED WITH PARADOXICAL ADIPOSE HYPERPLASIA (PAH/PH) TO THREE SEPARATE AREAS ON THE ABDOMEN.

    Description of Event or Problem · 0

    PREVIOUS EMDR SUBMISSION NOTED PARADOXICAL HYPERPLASIA. UPON FURTHER REVIEW BY ABBVIE MEDICAL SAFETY PHYSICIANS, IT HAS DETERMINED THAT THERE IS NO IDENTIFIABLE CASE OF PH OR ANY ADVERSE EVENT. HENCE, THE RECORD IS NO LONGER REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1758616 UNKNOWN COOLSCULPTING® SYSTEM DERMAL COOLING PACK/VACUUM/MASSAGER OOK ALLERGAN PLEASANTON NI

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Required Intervention