BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK COOLSCULPTING

    MDR report key: 12750212 · Received November 4, 2021

    Report

    Report Number
    3007215625-2021-01917
    Event Type
    Injury
    Date Received
    November 4, 2021
    Date of Event
    October 6, 2021
    Report Date
    August 27, 2022
    Manufacturer
    ALLERGAN PLEASANTON
    Product Code
    OOK
    PMA / PMN Number
    K160259
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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 3007215625-2021-01434-00.

    Description of Event or Problem · 0

    A TREATMENT PROVIDER REPORTED THAT A PATIENT TREATED WITH COOLSCULPTING PRESENTED WITH PAH.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1649357 UNK COOLSCULPTING DERMAL COOLING PACK/VACUUM/MASSAGER OOK ALLERGAN PLEASANTON NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention