BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOLSCULPTING SYSTEM

    MDR report key: 16923133 · Received May 12, 2023

    Report

    Report Number
    3007215625-2023-00637
    Event Type
    Injury
    Date Received
    May 12, 2023
    Date of Event
    May 2, 2023
    Report Date
    May 16, 2025
    Manufacturer
    ALLERGAN PLEASANTON
    Product Code
    OOK
    PMA / PMN Number
    K160259
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: AWARE DATE, B5. H10 - H11: CORRECTED DATA: SUBSEQUENT TO THE SUBMISSION OF INITIAL MEDWATCH, THIS REPORT HAS BEEN IDENTIFIED AS A DUPLICATE OF PREVIOUSLY SUBMITTED MEDWATCH REPORT OF 3007215625-2023-00637-00.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: D1 AND E1.

    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

    CORRECTION TO G.3. AWARE DATE OF SUPPLEMENTAL MEDWATCH # 1. AWARE DATE SHOULD HAVE BEEN LISTED AS 5/25/2023. IT HAS BEEN IDENTIFIED THAT THIS RECORD, MRN 3007215625-2023-00637, IS A DUPLICATE OF MRN 3007215625-2023-00559. PLEASE SEE MRN 3007215625-2023-00559 FOR REPORTABLE EVENTS. THIS RECORD IS NO LONGER REPORTABLE TO THE FDA AND WILL BE UN-REPORTED.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    ALLERGAN AESTHETICS RECEIVED A REPORT OF A PATIENT TREATED MID ABDOMEN ON (B)(6) 2022 WITH COOLSCULPTING COOLCORE MAY HAVE DEVELOPED PARADOXICAL HYPERPLASIA (PH).

    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
    1043734 COOLSCULPTING SYSTEM DERMAL COOLING PACK/VACUUM/MASSAGER OOK ALLERGAN PLEASANTON NI

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Unknown Required Intervention