BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN COOLSCULPTING SYSTEM

    MDR report key: 12155649 · Received July 12, 2021

    Report

    Report Number
    3007215625-2021-01442
    Event Type
    Injury
    Date Received
    July 12, 2021
    Date of Event
    May 21, 2021
    Report Date
    June 27, 2024
    Manufacturer
    ALLERGAN PLEASANTON
    Product Code
    OOK
    PMA / PMN Number
    -
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 3007215625-2021-01426-00.

    Additional Manufacturer Narrative · 0

    CORRECTION: B5, D1, D4, G1, G3, AND G6. H11: CORRECTED DATA: SUBSEQUENT TO THE SUBMISSION OF INITIAL MEDWATCH, THIS REPORT HAS BEEN IDENTIFIED AS A DUPLICATE OF PREVIOUSLY SUBMITTED MEDWATCH REPORT OF 3007215625-2021-01426-00.

    Description of Event or Problem · 0

    A TREATMENT PROVIDER REPORTED THEY HAVE A PATIENT WHO HAD MULTIPLE COOLSCULPTING TREATMENTS AND PRESENTED WITH PARADOXICAL HYPERPLASIA.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE SUBMISSION OF INITIAL MEDWATCH, THIS REPORT HAS BEEN IDENTIFIED AS A DUPLICATE OF PREVIOUSLY SUBMITTED MEDWATCH REPORT OF 3007215625-2021-01426-00.

    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 OF A PATIENT WHO RECEIVED MULTIPLE COOLSCULPTING TREATMENTS AND THE AREAS TREATED ARE APPEARING LARGER AND THE DENSITY AND FEEL OF THE FAT SEEMS TO HAVE CHANGED WHEN BEING PALPATED. POSSIBLE PARADOXICAL HYPERPLASIA HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1051552 UNKNOWN COOLSCULPTING SYSTEM DERMAL COOLING PACK/VACUUM/MASSAGER OOK ALLERGAN PLEASANTON NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention