BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOLSCULPTING SYSTEM

    MDR report key: 16902780 · Received May 9, 2023

    Report

    Report Number
    MW5117411
    Event Type
    Injury
    Date Received
    May 9, 2023
    Date of Event
    October 25, 2022
    Report Date
    May 9, 2023
    Manufacturer
    ABBVIE IRELAND NL B.V. BALLYTIVNAN
    Product Code
    OOK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT CALLED TO REPORT AN ADVERSE REACTION TO COOLSCULPTING PROCEDURE. PATIENT STATED SHE HAD A COOLSCULPTING PROCEDURE ON HER UPPER ABDOMEN END OF (B)(6) 2022 AND IT SEEMED TO HAVE WORKED FINE. PATIENT STATED SHE HAD ANOTHER TREATMENT DONE WITH NO CHANGE, BUT SHE FELT BIGGER, AND SHE NOTICED HER UPPER ABDOMEN LOOKED DIFFERENT AND NOT FLATTER. PATIENT SAID SHE BECAME A LITTLE WORRIED ABOUT HOW THE AREA ON HER ABDOMEN LOOKED AND HAD A ZOOM MEETING WITH THE PLACE SHE RECEIVED THE TREATMENT, AND THEY RECOMMENDED MORE TREATMENT FOR HER. PATIENT STATED SHE WENT BACK IN (B)(6) OF 2023 FOR ANOTHER TREATMENT AND AFTERWARD SHE NOTICED SHE WAS LOOKING EVEN BIGGER, AND THINGS WERE NOT LOOKING GOOD. PATIENT SAID SHE WENT BACK A FEW WEEKS LATER AS SHE AGAIN WAS WORRIED ABOUT THE HARD LUMP ON HER ABDOMEN, AND THEY RECOMMENDED SHE SEE HER DOCTOR. PATIENT SAID SHE SAW HER MEDICAL DOCTOR WHO AGREED IT¿S ABNORMALLY SHAPED. PATIENT STATED SHE WENT BACK AGAIN ABOUT 6 WEEKS AGO TO MEET WITH THE NURSE AT THE COOLSCULPTING PLACE TO HAVE HER LOOK AT THE LUMP ON HER ABDOMEN. PATIENT STATED SHE DID SOME RESEARCH ON HER OWN AND CAME ACROSS PAH (PARADOXICAL ADIPOSE HYPERPLASIA) AND REALIZED THAT IS EXACTLY WHAT¿S GOING ON WITH HER. PATIENT SAID SHE WENT BACK TO THE COOLSCULPTING PLACE ABOUT 2 WEEKS AGO AND THEY CONFIRMED SHE DID SEEM TO HAVE PAH. PATIENT STATED SHE CAN¿T FIT INTO HER CLOTHES ANYMORE AND THE LUMP ON HER ABDOMEN IS THE SHAPE OF THE APPLICATOR USED DURING THE PROCEDURE. PATIENT STATED SHE LOOKS LIKE SHE¿S 6 MONTHS PREGNANT AND THAT HER ABDOMEN IS DEFORMED. PATIENT WAS TOLD THE ONLY WAY TO RECTIFY THIS ISSUE IS TO HAVE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    882519 COOLSCULPTING SYSTEM DERMAL COOLING PACK/VACUUM/MASSAGER OOK ABBVIE IRELAND NL B.V. BALLYTIVNAN

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Other