BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOLSCULPTING SYSTEM

    MDR report key: 12425311 · Received September 3, 2021

    Report

    Report Number
    3007215625-2021-01578
    Event Type
    Injury
    Date Received
    September 3, 2021
    Date of Event
    July 22, 2021
    Report Date
    May 27, 2025
    Manufacturer
    ALLERGAN PLEASANTON
    Product Code
    OOK
    PMA / PMN Number
    -
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 3007215625-2021-01725-00.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: B5, D1, D4.

    Description of Event or Problem · 0

    A TREATMENT PROVIDER REPORTED THEY HAVE A PATIENT WHO PRESENTED WITH PARADOXICAL HYPERPLASIA POST COOLSCULPTING TREATMENT.

    Description of Event or Problem · 0

    UPON FURTHER REVIEW OF THE REPORTED EVENT, THIS REPORT HAS BEEN IDENTIFIED AS A DUPLICATE REPORT.

    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 AESTHETICS RECEIVED A REPORT OF A PATIENT WHO WAS TREATED TO THE SUBMENTAL AREA USING THE COOLMINI APPLICATOR AND HAS PRESENTED WITH PARADOXICAL HYPERPLASIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1318618 COOLSCULPTING SYSTEM DERMAL COOLING PACK/VACUUM/MASSAGER OOK ALLERGAN PLEASANTON NI

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Unknown Required Intervention