BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOLSCULPTING SYSTEM

    MDR report key: 17576068 · Received August 18, 2023

    Report

    Report Number
    3007215625-2023-13167
    Event Type
    Injury
    Date Received
    August 18, 2023
    Report Date
    November 22, 2023
    Manufacturer
    ALLERGAN (PLEASANTON)
    Product Code
    OOK
    PMA / PMN Number
    K160259
    Removal / Correction Number
    Z-1348-2022, Z-1347-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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 COOL SCULPTING 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 COOL SCULPTING 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.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA D1 - BRAND NAME.

    Description of Event or Problem · 0

    ALLERGAN AESTHETICS RECEIVED A REPORT OF A PATIENT TREATED WITH COOL SCULPTING TO BILATERAL FLANKS ON (B)(6) 2016 USING COOL CURVE+ APPLICATOR, TO SUBMENTAL ON (B)(6) 2016 USING COOLMINI APPLICATOR, AND TO LOWER ABDOMEN ON (B)(6) 2016 USING COOL CORE APPLICATOR WHO DEVELOPED PARADOXICAL HYPERPLASIA (PAH/PH) AN UNSPECIFIED AMOUNT OF TIME AFTER TREATMENT. PAH WAS DIAGNOSED IN ABDOMEN, FLANKS, AND SUBMENTAL ON (B)(6) 2017. MA CONFIRMED PAH IN LOWER ABDOMEN AND FLANKS, THE SUBMENTAL WAS CONSIDERED NOT CONSISTENT WITH PAH.

    Description of Event or Problem · 0

    ALLERGAN AESTHETICS RECEIVED A REPORT OF A PATIENT TREATED WITH COOLSCULPTING TO BILATERAL FLANKS ON (B)(6) 2016 USING COOLCURVE+ APPLICATOR, TO SUBMENTAL ON (B)(6) 2016 USING COOLMINI APPLICATOR, AND TO LOWER ABDOMEN ON (B)(6) 2016 USING COOLCORE APPLICATOR WHO DEVELOPED PARADOXICAL HYPERPLASIA (PAH/PH) AN UNSPECIFIED AMOUNT OF TIME AFTER TREATMENT. PAH WAS DIAGNOSED IN ABDOMEN, FLANKS, AND SUBMENTAL ON (B)(6) 2017. MA CONFIRMED PAH IN LOWER ABDOMEN AND FLANKS, THE SUBMENTAL WAS CONSIDERED NOT CONSISTENT WITH PAH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2166904 COOLSCULPTING SYSTEM DERMAL COOLING PACK/VACUUM/MASSAGER OOK ALLERGAN (PLEASANTON) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Male Required Intervention