BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN COOLSCULPTING SYSTEM

    MDR report key: 15406375 · Received September 12, 2022

    Report

    Report Number
    3007215625-2022-01386
    Event Type
    Injury
    Date Received
    September 12, 2022
    Date of Event
    March 1, 2022
    Report Date
    May 2, 2024
    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

    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 OBSERVED MORE FREQUENTLY WITH THE PARALLEL PLATE APPLICATORS. PAH IS INCLUDED IN THE RISK MANAGEMENT FILES OF THE DEVICE AS AN INHERENT RISK TO THE USE OF CRYOLIPOLYSIS FOR LOCALIZED FAT REDUCTION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF AND WHEN ADDITIONAL INFORMATION IS OBTAINED.

    Additional Manufacturer Narrative · 0

    H11-: CORRECTED DATA: SUBSEQUENT TO THE SUBMISSION OF INITIAL MEDWATCH, THIS REPORT HAS BEEN IDENTIFIED AS A DUPLICATE OF PREVIOUSLY SUBMITTED MEDWATCH REPORT OF 3007215625-2022-00924-00.

    Additional Manufacturer Narrative · 0

    SUBSEQUENT TO THE SUBMISSION OF INITIAL MEDWATCH, THIS REPORT HAS BEEN IDENTIFIED AS A DUPLICATE OF PREVIOUSLY SUBMITTED MEDWATCH REPORT OF 3007215625-2022-00924-00.

    Description of Event or Problem · 0

    ALLERGAN AESTHETICS RECEIVED A REPORT OF A PATIENT TREATED SUBMENTAL, FLANKS, AND ABDOMEN ON (B)(6) 2021 WITH COOLSCULPTING C80 AND C150 MY HAVE DEVELOPED PARADOXICAL HYPERPLASIA (PAH/PH). DUE TO INSUFFICIENT INFORMATION, DEVICE INFO IS NOT DOCUMENTED.

    Description of Event or Problem · 0

    A PATIENT REPORTED THAT SHE PATIENT RECEIVED COOLSCULPTING TREATMENT TO THE FULL ABDOMEN AND CHIN ON (B)(6) 2021 AND PRESENTED WITH POSSIBLE PAH.

    Description of Event or Problem · 0

    UPON FURTHER REVIEW OF THE REPORTED EVENT, THIS REPORT¿HAS BEEN IDENTIFIED AS A DUPLICATE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2607929 UNKNOWN COOLSCULPTING SYSTEM DERMAL COOLING PACK/VACUUM/MASSAGER OOK ALLERGAN PLEASANTON NI

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Female Required Intervention