BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOLSCULPTING SYSTEM

    MDR report key: 11807898 · Received May 11, 2021

    Report

    Report Number
    3007215625-2021-01282
    Event Type
    Injury
    Date Received
    May 11, 2021
    Date of Event
    August 20, 2020
    Report Date
    February 27, 2025
    Manufacturer
    ALLERGAN PLEASANTON
    Product Code
    OOK
    PMA / PMN Number
    K160259
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA. SUPPLEMENTAL MEDWATCH IS BEING SUBMITTED TO CORRECT THE G3 FIELD WHICH WAS LEFT BLANK IN THE PREVIOUSLY SUBMITTED MEDWATCH.

    Additional Manufacturer Narrative · 0

    CORRECTION TO G.3. AWARE DATE OF INITIAL MEDWATCH 3007215625-2021-01282. AWARE DATE SHOULD HAVE BEEN LISTED AS 15/APRIL/2021. CORRECTION TO G.3. AWARE DATE OF SUPPLEMENTAL MEDWATCH 3007215625-2021-01282-1. AWARE DATE SHOULD HAVE BEEN LISTED AS 08/FEB/2023. 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) 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. PH 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

    A TREATMENT PROVIDER REPORTED THAT A PATIENT TREATED ON (B)(6) 2020 TO THE LOWER ABDOMEN AND FLANKS USING THE COOLADVANTAGE PLUS HAS BEEN DIAGNOSED WITH PARADOXICAL HYPERPLASIA. THE TISSUE IS DESCRIBED AS FIRM AND THERE IS VISIBLE VOLUME INCREASE IN TREATED AREAS.

    Description of Event or Problem · 0

    ALLERGAN AESTHETICS RECEIVED A REPORT THAT A PATIENT RECEIVED A COOLSCULPTING TREATMENT TO THE LOWER ABDOMEN AND FLANKS ON (B)(6)2020 USING THE COOLADVANTAGE PLUS AND COOLADVANTAGE APPLICATORS AND PRESENTED WITH PARADOXICAL HYPERPLASIA (PH).

    Additional Manufacturer Narrative · 1

    THE FOLLOWING INFORMATION IS IN THE COOLSCULPTING USER MANUAL: PARADOXICAL HYPERPLASIA 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. INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    A TREATMENT PROVIDER REPORTED THAT A PATIENT TREATED ON (B)(6) 2020 TO THE LOWER ABDOMEN AND FLANKS USING THE COOLADVANTAGE PLUS HAS BEEN DIAGNOSED WITH PARADOXICAL HYPERPLASIA. THE TISSUE IS DESCRIBED AS FIRM AND THERE IS VISIBLE VOLUME INCREASE IN TREATED AREAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700439 COOLSCULPTING SYSTEM DERMAL COOLING PACK/VACUUM/MASSAGER OOK ALLERGAN PLEASANTON NI

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Male Required Intervention