BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN COOLSCULPTING SYSTEM

    MDR report key: 12089118 · Received June 29, 2021

    Report

    Report Number
    3007215625-2021-01416
    Event Type
    Injury
    Date Received
    June 29, 2021
    Date of Event
    November 1, 2015
    Report Date
    May 15, 2024
    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

    H11: CORRECTED DATA: SUBSEQUENT TO THE SUBMISSION OF INITIAL MEDWATCH, THIS REPORT HAS BEEN IDENTIFIED AS A DUPLICATE OF PREVIOUSLY SUBMITTED MEDWATCH REPORT OF 3007215625-2021-01834-00.

    Description of Event or Problem · 0

    A PATIENT REPORTED THAT THEY HAD RECEIVED COOLSCULPTING TREATMENT TO THE ABDOMEN, BRA AREA, FLANKS, AXILLARY PUFF, UPPER ABDOMEN ON (B)(6) 2015 EXPERIENCING PARADOXICAL ADIPOSE HYPERPLASIA.

    Description of Event or Problem · 0

    ALLERGAN AESTHETICS RECEIVED A REPORT OF A PATIENT WHO RECEIVED COOLSCULPTING TREATMENT TO THE ABDOMEN, FLANKS AND INFRA-SCAPULAR AREA IN (B)(6) 2015 AND DEVELOPED PARADOXICAL HYPERPLASIA (PH) POST TREATMENT. PATIENT DIAGNOSED WITH PH (B)(6) 2022.

    Additional Manufacturer Narrative · 1

    THE FOLLOWING INFORMATION IS IN THE COOLSCULPTING USER MANUAL: PARADOXICAL 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. INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    ALLERGAN RECEIVED A REPORT THAT A PATIENT RECEIVED COOLSCULPTING TREATMENT TO THE UPPER ABDOMEN, BRA AREA, FLANKS, AXILLARY PUFF AND IS EXPERIENCING PARADOXICAL HYPERPLASIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    985444 UNKNOWN COOLSCULPTING SYSTEM DERMAL COOLING PACK/VACUUM/MASSAGER OOK ALLERGAN PLEASANTON NI

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female Required Intervention