BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOLSCULPTING SYSTEM

    MDR report key: 17408456 · Received July 27, 2023

    Report

    Report Number
    3007215625-2023-11021
    Event Type
    Injury
    Date Received
    July 27, 2023
    Date of Event
    July 15, 2013
    Report Date
    November 13, 2023
    Manufacturer
    ALLERGAN (PLEASANTON)
    Product Code
    OOK
    PMA / PMN Number
    K160259
    Removal / Correction Number
    Z-1347-2022;Z-1346-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    "H.9 CONTINUED: ADDITIONAL CORRECTION REMOVAL NUMBERS: Z?????, Z????" 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 FEMALE PATIENT WAS TREATED ON (B)(6) 2013 WITH COOLSCULPTING TO THE LOWE ABDOMEN USING 6.3 COOLCORE AND 8.0 COOLMAX ON (B)(6) 2012 USING TWO EZ 8 APPLICATORS TO HER LOWER ABDOMEN AND ONE EZ 8 APPLICATOR TO HER MID ABDOMEN. ON (B)(6) 2012 USING ONE EZ ZELTIQ EZ APP 8.0 COOLMAX APPLICATOR TO HER MID ABDOMEN.ON (B)(6) 2012 AND HAD TWO 6.3 COOLCORE APPLICATORS TO HER LOWER ABDOMEN.ON (B)(6) 2013 USING 2 EZ ZELTIQ EZ APP8.0 COOLMAX APPLICATORS TO HER LOWER ABDOMEN.ON (B)(6) 2013 PATIENT HAD AN EZ ZELTIQ EZ APP8.0 COOLMAX APPLICATOR TO HER MID ABDOMEN.ON (B)(6) 2013 AND HAD HER RIGHT LOWER ABDOMEN TREATED WITH A 6.3 COOLCORE APPLICATOR FOR 90 MINUTES.ON (B)(6) 2013 THE PATIENT HAS DEVELOPED PARADOXICAL HYPERPLASIA IN LOWER ABDOMEN WITH TWO MAIN CHARACTERISTICS WHICH ARE OBVIOUS RE GROWTH OF FAT CELLS AND A HARDENING OF THE BULGE.

    Description of Event or Problem · 0

    ALLERGAN AESTHETICS RECEIVED A REPORT OF A FEMALE PATIENT WAS TREATED ON (B)(6) 2013 WITH COOLSCULPTING TO THE LOWER ABDOMEN USING 6.3 COOLCORE AND 8.0 COOLMAX ON (B)(6) 2012 USING TWO EZ 8 APPLICATORS TO HER LOWER ABDOMEN AND ONE EZ 8 APPLICATOR TO HER MID ABDOMEN. ON (B)(6) 2012 USING ONE EZ ZELTIQ EZ APP 8.0 COOLMAX APPLICATOR TO HER MID ABDOMEN. ON (B)(6) 2012 AND HAD TWO 6.3 COOLCORE APPLICATORS TO HER LOWER ABDOMEN. ON (B)(6) 2013 USING 2 EZ ZELTIQ EZ APP8.0 COOLMAX APPLICATORS TO HER LOWER ABDOMEN. ON (B)(6) 2013 PATIENT HAD AN EZ ZELTIQ EZ APP8.0 COOLMAX APPLICATOR TO HER MID ABDOMEN. ON (B)(6) 2013 AND HAD HER RIGHT LOWER ABDOMEN TREATED WITH A 6.3 COOLCORE APPLICATOR FOR 90 MINUTES. ON (B)(6) 2013 THE PATIENT HAS DEVELOPED PARADOXICAL HYPERPLASIA IN LOWER ABDOMEN WITH TWO MAIN CHARACTERISTICS WHICH ARE OBVIOUS RE GROWTH OF FAT CELLS AND A HARDENING OF THE BULGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1223013 COOLSCULPTING SYSTEM DERMAL COOLING PACK/VACUUM/MASSAGER OOK ALLERGAN (PLEASANTON) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Required Intervention