BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOLSCULPTING SYSTEM

    MDR report key: 23871495 · Received December 22, 2025

    Report

    Report Number
    3007215625-2025-00893
    Event Type
    Injury
    Date Received
    December 22, 2025
    Date of Event
    August 1, 2025
    Report Date
    December 22, 2025
    Manufacturer
    ALLERGAN PLEASANTON
    Product Code
    OOK
    UDI-DI
    00816417020001
    PMA / PMN Number
    K160259
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PARADOXICAL ADIPOSE HYPERPLASIA (PH) IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING. ACCORDING TO THE COOLSCULPTING USER MANUAL, UNDER RARE ADVERSE EVENTS, PH 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. PH IS NOT RELATED TO ANY COOLSCULPTING DEVICE FAILURE MODE BUT IT IS INCLUDED IN THE RISK MANAGEMENT FILES OF THE DEVICE BECAUSE IT IS A RISK THAT IS INHERENT TO THE USE CRYOLIPOLYSIS FOR LOCALIZED FAT REDUCTION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF AND WHEN ADDITIONAL INFORMATION IS OBTAINED. COOLSCULPTING SYSTEM SERIAL NUMBER: (B)(4) CATALOG NUMBER: SA16789 LOT NUMBER: NI UDI: (01)00816417020001(21) (B)(4)(11)230223(17)991231 MANUFACTURING DATE: 02/23/2023. COOLSCULPTING SYSTEM SERIAL NUMBER: (B)(4) CATALOG NUMBER: SA16789 LOT NUMBER: NI UDI: (01)00816417020001(21) (B)(4)(11)230223(17)991231 MANUFACTURING DATE: 02/23/2023.

    Description of Event or Problem · 0

    A PROVIDER REPORTED THAT A PATIENT RECEIVED A COOLSCULPTING TREATMENT TO THE SUBMENTAL AREA ON (B)(6) /2025 USING THE COOLMINI APPLICATOR AND PRESENTED WITH POSSIBLE PARADOXICAL HYPERPLASIA (PH) AND "ENLARGED AREA" 6 MONTHS POST TREATMENT. LATER HEALTHCARE PROFESSIONAL REPORTED "SOME TENDERNESS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2328843 COOLSCULPTING SYSTEM DERMAL COOLING PACK/VACUUM/MASSAGER OOK ALLERGAN PLEASANTON NI 00816417020001

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Female Required Intervention (B)(4)