BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOLSCULPTING SYSTEM

    MDR report key: 13999210 · Received April 4, 2022

    Report

    Report Number
    3007215625-2022-00486
    Event Type
    Injury
    Date Received
    April 4, 2022
    Date of Event
    January 1, 2022
    Report Date
    December 11, 2023
    Manufacturer
    ALLERGAN PLEASANTON
    Product Code
    OOK
    UDI-DI
    00816417020001
    PMA / PMN Number
    K160259
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE COOLSCULPTING USER MANUAL, UNDER RARE ADVERSE EVENTS, PARADOXICAL ADIPOSE 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. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF AND WHEN ADDITIONAL INFORMATION IS OBTAINED.

    Additional Manufacturer Narrative · 0

    CORRECTION TO PREVIOUS EMDR - WHEN ADDITIONAL INFO. WAS RECEIVED: EMDR-11725 BECOME AWARE DATE (G3): 4/25/2022.

    Description of Event or Problem · 0

    (B)(6) RECEIVED A REPORT OF A PATIENT TREATED WITH COOLSCULPTING DEVELOPED PARADOXICAL HYPERPLASIA (PAH/PH).

    Description of Event or Problem · 0

    ALLERGAN AESTHETICS RECEIVED A REPORT OF A PATIENT TREATED WITH COOLSCULPTING DEVELOPED PARADOXICAL HYPERPLASIA (PAH/PH).

    Description of Event or Problem · 0

    ALLERGAN AESTHETICS RECEIVED A REPORT OF A PATIENT TREATED WITH COOLSCULPTING TO THE LOWER ABDOMEN ON (B)(6) 2020 & (B)(6) 2021 USING COOLADVANTAGE SYSTEM APPLICATORS, WHO MAY HAVE DEVELOPED PARADOXICAL HYPERPLASIA (PH) AFTER TREATMENT. HEALTHCARE PROFESSIONAL INDICATED "LIPO MASSAGE [UNKNOWN WORD]" ON CLINICAL EVENT FORM (CEF). APPLICATORS USED: V1602019084010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1264714 COOLSCULPTING SYSTEM DERMAL COOLING PACK/VACUUM/MASSAGER OOK ALLERGAN PLEASANTON NI 00816417020001

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male Required Intervention