BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK COOLSCULPTING

    MDR report key: 13369428 · Received January 27, 2022

    Report

    Report Number
    3007215625-2022-00160
    Event Type
    Injury
    Date Received
    January 27, 2022
    Date of Event
    January 5, 2022
    Report Date
    September 13, 2022
    Manufacturer
    ALLERGAN PLEASANTON
    Product Code
    OOK
    UDI-DI
    00816417020001
    PMA / PMN Number
    K160259
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PHYSICIAN
    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

    H11-: CORRECTED DATA: SUBSEQUENT TO THE SUBMISSION OF INITIAL MEDWATCH, THIS REPORT HAS BEEN IDENTIFIED AS A DUPLICATE OF PREVIOUSLY SUBMITTED MEDWATCH REPORT OF 3007215625-2022-00319-00.

    Description of Event or Problem · 0

    ALLERGAN AESTHETICS RECEIVED A REPORT OF A PATIENT WHO WAS TREATED WITH COOLSCULPTING TO THE BILATERAL FLANKS AND MAY HAVE DEVELOPED PARADOXICAL HYPERPLASIA.

    Description of Event or Problem · 0

    (B)(6). I ATTACH INFORMATION: INFORMED CONSENT PHOTOS ( BEFORE AND AFTER) I REMAIN ATTENTIVE TO YOUR ANSWER. THANK YOU!

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258142 UNK COOLSCULPTING DERMAL COOLING PACK/VACUUM/MASSAGER OOK ALLERGAN PLEASANTON NI 00816417020001

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Required Intervention