BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN COOLSCULPTING SYSTEM

    MDR report key: 12465271 · Received September 13, 2021

    Report

    Report Number
    3007215625-2021-01608
    Event Type
    Injury
    Date Received
    September 13, 2021
    Date of Event
    August 12, 2021
    Report Date
    May 23, 2024
    Manufacturer
    ALLERGAN PLEASANTON
    Product Code
    OOK
    PMA / PMN Number
    K160259
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IT HAS BEEN IDENTIFIED THAT THIS RECORD, MRN 3007215625-2021-01608, IS A DUPLICATE OF MRN 3007215625-2021-01808. PLEASE SEE MRN 3007215625-2021-01808 FOR REPORTABLE EVENTS.

    Description of Event or Problem · 0

    PREVIOUS EMDR SUBMISSION NOTED PARADOXICAL HYPERPLASIA. UPON FURTHER REVIEW OF INFORMATION, ALLERGAN AESTHETICS HAS DETERMINED THAT THIS RECORD IS A DUPLICATE RECORD. PLEASE SEE EMDR-02347 AS THE OPERATING RECORD RELATED TO THIS COMPLAINT.

    Additional Manufacturer Narrative · 1

    THIS MANDATORY REPORT IS BEING SUBMITTED AFTER ALLERGAN AESTHETICS RECEIVED A COPY OF VOLUNTARY REPORT MW 5102843. 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

    A PATIENT REPORTED THAT FOLLOWING COOLSCULPTING TREATMENT, THEY DEVELOPED PARADOXICAL HYPERPLASIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1361789 UNKNOWN COOLSCULPTING SYSTEM DERMAL COOLING PACK/VACUUM/MASSAGER OOK ALLERGAN PLEASANTON NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention