BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOLSCULPTING SYSTEM

    MDR report key: 17552804 · Received August 15, 2023

    Report

    Report Number
    3007215625-2023-12756
    Event Type
    Injury
    Date Received
    August 15, 2023
    Report Date
    November 21, 2023
    Manufacturer
    ALLERGAN (PLEASANTON)
    Product Code
    OOK
    PMA / PMN Number
    K160259
    Removal / Correction Number
    Z-1347-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA D1 - BRAND NAME.

    Additional Manufacturer Narrative · 0

    THIS IS A HISTORICAL RECORD AND REFLECTS REPORTS THAT WERE RECEIVED BY THE COMPANY PRIOR TO APRIL 2021. THIS MDR IS ASSOCIATED WITH A PARALLEL PLATE APPLICATOR, THESE APPLICATORS WERE DISCONTINUED AND RECALLED IN 2022. 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 OBSERVED MORE FREQUENTLY WITH THE PARALLEL PLATE APPLICATORS. PAH IS INCLUDED IN THE RISK MANAGEMENT FILES OF THE DEVICE AS AN INHERENT RISK TO THE USE OF CRYOLIPOLYSIS FOR LOCALIZED FAT REDUCTION.

    Description of Event or Problem · 0

    ALLERGAN AESTHETICS RECEIVED A REPORT OF A PATIENT TREATED WITH COOLSCULPTING ON (B)(6) 2016 TO THE LOWER ABDOMEN USING A COOLCORE APPLICATOR WHO DEVELOPED PARADOXICAL HYPERPLASIA (PAH/PH) OF THE TREATED AREA ON AN UNKNOWN DATE AFTER TREATMENT, DIAGNOSED ON (B)(6) 2017. TISSUE DESCRIBED AS FIR M, SOLID AND HARDER COMPARED TO THE SURROUNDING TISSUE WHICH WAS SQUISHY. THE HARDENED AREA ALSO HAD SOME DEMARCATION OF WHERE THE APPLICATOR WAS PLACE.

    Description of Event or Problem · 0

    ALLERGAN AESTHETICS RECEIVED A REPORT OF A PATIENT TREATED WITH COOLSCULPTING ON (B)(6) 2016 TO THE LOWER ABDOMEN USING A COOLCORE APPLICATOR WHO DEVELOPED PARADOXICAL HYPERPLASIA (PAH/PH) OF THE TREATED AREA ON AN UNKNOWN DATE AFTER TREATMENT, DIAGNOSED ON (B)(6) 2017. TISSUE DESCRIBED AS FIR M, SOLID AND HARDER COMPARED TO THE SURROUNDING TISSUE WHICH WAS SQUISHY. THE HARDENED AREA ALSO HAD SOME DEMARCATION OF WHERE THE APPLICATOR WAS PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    962901 COOLSCULPTING SYSTEM DERMAL COOLING PACK/VACUUM/MASSAGER OOK ALLERGAN (PLEASANTON) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Female Required Intervention