BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN COOLSCULPTING SYSTEM

    MDR report key: 14294333 · Received May 5, 2022

    Report

    Report Number
    3007215625-2022-00683
    Event Type
    Injury
    Date Received
    May 5, 2022
    Date of Event
    April 10, 2019
    Report Date
    November 15, 2023
    Manufacturer
    ALLERGAN PLEASANTON
    Product Code
    OOK
    PMA / PMN Number
    K160259
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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: A2 B5 D1 G1 H6.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    ALLERGAN AESTHETICS RECEIVED AN UPDATED CEF FORM ON 08/04/2022 WITH THE ABDOMEN ADDED AS AREA OF CONCERN. TREATED AREAS: ABDOMEN AND BACK, TREATMENT DATE (B)(6) 2019. (INITIAL (B)(4)) DIAGNOSED WITH PAH ON (B)(6) 2022 BY APRN.

    Description of Event or Problem · 0

    ALLERGAN AESTHETICS RECEIVED A REPORT OF A PATIENT TREATED WITH COOLSCULPTING TO THE LOWER ABDOMEN AND BRA ROLLS (BACK AREA). TREATMENT DATES INCLUDE (B)(6) 2019 AND (B)(6) 2022. PATIENT DEVELOPED PARADOXICAL HYPERPLASIA (PH) AFTER TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1693657 UNKNOWN COOLSCULPTING SYSTEM DERMAL COOLING PACK/VACUUM/MASSAGER OOK ALLERGAN PLEASANTON NI

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Female Required Intervention