BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN COOLSCULPTING SYSTEM

    MDR report key: 18489222 · Received January 10, 2024

    Report

    Report Number
    3007215625-2024-00037
    Event Type
    Injury
    Date Received
    January 10, 2024
    Report Date
    January 10, 2024
    Manufacturer
    ALLERGAN PLEASANTON
    Product Code
    OOK
    PMA / PMN Number
    K160259
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PARADOXICAL ADIPOSE HYPERPLASIA (PH/PAH) IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING. ACCORDING TO THE COOLSCULPTING USER MANUAL, UNDER RARE ADVERSE EVENTS, PARADOXICAL ADIPOSE HYPERPLASIA (PH/PAH) 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. PAH 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: ADDITIONAL AREA DESIGNATED FLANKS TO THE ABDOMEN (PREVIOUS DOCUMENTED).

    Description of Event or Problem · 0

    ALLERGAN AESTHETICS RECEIVED A REPORT FROM A FEMALE PATIENT WHO RECEIVED COOLSCULPTING TREATMENT TO THE THIGHS ON (B)(6) 2015 AND DEVELOPED PARADOXICAL ADIPOSE HYPERPLASIA (PAH/PH) TO THE OUTER THIGHS AFTER TREATMENT. THE INNER THIGHS WERE ADDRESSED IN A PRIOR REPORT. IN ADDITION, THE PATIENT INDICATED THAT THE ABDOMEN, ARMS, AND SUBMENTAL AREA HAD THE POSSIBLE PARADOXICAL ADIPOSE HYPERPLASIA (PAH/PH) DEVELOPMENT [PATIENT DID NOT PROVIDE OBJECTIVE EVIDENCE OF COOLSCULPTING DEVICE USE IN THOSE AREAS]. [ PRIOR MDR REPORT: REPORT REF#: 3007215625-2022-01424-02 / MFR#: 3007215625-2022-01424 FOLLOW-UP # 2].

    Description of Event or Problem · 0

    ALLERGAN AESTHETICS RECEIVED A REPORT FROM A FEMALE PATIENT WHO RECEIVED COOLSCULPTING TREATMENT TO THE THIGHS ON 04-JUNE-2015 AND DEVELOPED PARADOXICAL ADIPOSE HYPERPLASIA (PAH/PH) TO THE OUTER THIGHS AFTER TREATMENT. THE INNER THIGHS WERE ADDRESSED IN A PRIOR REPORT. IN ADDITION, THE PATIENT INDICATED THAT THE ABDOMEN, ARMS, AND SUBMENTAL AREA HAD THE POSSIBLE PARADOXICAL ADIPOSE HYPERPLASIA (PAH/PH) DEVELOPMENT [PATIENT DID NOT PROVIDE OBJECTIVE EVIDENCE OF COOLSCULPTING DEVICE USE IN THOSE AREAS]. [ PRIOR MDR REPORT: REPORT REF # 3007215625-2022-01424-02 / MFR # 3007215625-2022-01424 FOLLOW-UP # 2 ].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    888095 UNKNOWN COOLSCULPTING SYSTEM DERMAL COOLING PACK/VACUUM/MASSAGER OOK ALLERGAN PLEASANTON NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention