BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOLSCULPTING SYSTEM

    MDR report key: 17077648 · Received June 7, 2023

    Report

    Report Number
    3007215625-2023-10034
    Event Type
    Injury
    Date Received
    June 7, 2023
    Date of Event
    October 23, 2020
    Report Date
    November 8, 2023
    Manufacturer
    ALLERGAN (PLEASANTON)
    Product Code
    OOK
    UDI-DI
    00816417020001
    PMA / PMN Number
    K160259
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A HISTORICAL RECORD AND REFLECTS REPORTS THAT WERE RECEIVED BY THE COMPANY PRIOR TO (B)(6) 2021. 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.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA D1: BRAND NAME.

    Description of Event or Problem · 0

    ALLERGAN AESTHETICS RECEIVED A REPORT OF A PATIENT TREATED WITH COOLSCULPTING TO BRA-ROLL (BACK) ON (B)(6) 2020 USING THE COOLADVANTAGE+, COOLCURVE+ CONTOUR APPLICATORS. A SECOND TREATMENT OCCURRED ON THE SUBMENTAL ON (B)(6) 2020 WITH THE SAME APPLICATORS. PATIENT DEVELOPED PARADOXICAL HYPERPLASIA (PAH/PH) ON UPPER AND MID BACK (BRA FAT AREA) AFTER TREATMENT, DIAGNOSED ON (B)(6) 2020. MODERATE BRUISING OCCURRED AFTER BOTH TREATMENTS AND "LOP POST 1ST SESSION" RESOLVED WITHOUT MEDICATION. PHYSICIAN DESCRIBED TISSUE AS "FIRM TO TOUCH - ENLARGED AREA ONLY AT POINT OF APPLICATOR CONTACT" WITH "VISIBLE ENLARGEMENT".

    Description of Event or Problem · 0

    ALLERGAN AESTHETICS RECEIVED A REPORT OF A PATIENT TREATED WITH COOLSCULPTING TO BRA-ROLL (BACK) ON (B)(6) 2020 USING THE COOLADVANTAGE+, COOLCURVE+ CONTOUR APPLICATORS. A SECOND TREATMENT OCCURRED ON THE SUBMENTAL ON (B)(6) 2020 WITH THE SAME APPLICATORS. PATIENT DEVELOPED PARADOXICAL HYPERPLASIA (PAH/PH) ON UPPER AND MID BACK (BRA FAT AREA) AFTER TREATMENT, DIAGNOSED ON (B)(6) 2020. MODERATE BRUISING OCCURRED AFTER BOTH TREATMENTS AND "LOP POST 1ST SESSION" RESOLVED WITHOUT MEDICATION. PHYSICIAN DESCRIBED TISSUE AS "FIRM TO TOUCH - ENLARGED AREA ONLY AT POINT OF APPLICATOR CONTACT" WITH "VISIBLE ENLARGEMENT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    956666 COOLSCULPTING SYSTEM DERMAL COOLING PACK/VACUUM/MASSAGER OOK ALLERGAN (PLEASANTON) BRZ-CG1-CUD-110 NI 00816417020001

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Required Intervention