BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORIGINAL COOL SCUPLT; COOL SCULPT BY ALLERGAN AND SCULPTURE CYNOSURE

    MDR report key: 16910433 · Received May 10, 2023

    Report

    Report Number
    MW5117441
    Event Type
    Injury
    Date Received
    May 10, 2023
    Date of Event
    November 24, 2015
    Report Date
    May 8, 2023
    Manufacturer
    ALLERGAN/ABBVIE IRELAND NL B.V. BALLYTIVNAN
    Product Code
    OOK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I HAVE HAD 3 COOL SCULPT PROCEDURES: 2 IN 2015 AND 1 IN 2018 (2 DATES); AT 3 DIFFERENT OFFICES. THE IDEA PRESENTED TO ME WAS THAT MORE THAN ONE TIME MIGHT BE NEEDED. I BELIEVE I AM ONE OF THE PEOPLE THAT THE PROCEDURE RESULTED IN PAH: PARADOXICAL ADIPOSE HYPERPLASIA. I HAVE WONDERED EVER SINCE THE PROCEDURES IF THERE WAS SOMETHING NOT RIGHT ABOUT THE RESULT AND IT WAS ONLY A FEW WEEKS AGO WHEN I SAW ON THE NEWS THAT THIS HAS HAPPENED TO OTHERS! I WAS SO RELIEVED THAT ALL THESE YEARS I WAS CORRECT IN THINKING THAT THE PROCEDURES ACTUALLY MADE ME WORSE AND EVEN LOSING WEIGHT DOESN'T HELP. I DON'T WANT TO TRY TO KEEP LOSING AND STILL HAVE A PREGNANT BELLY! I AM NOT A BIG PERSON AT ALL. I'M ABOUT 5'4'' AND WEIGH ABOUT 127. I AM NOT SURE IF THERE IS ANY HELP AVAILABLE TO REMEDY THE SITUATION OR NOT. I BELIEVE THE COMPANIES ARE THE ORIGINAL COOL SCULPT, ALLERGAN AND SCULPTURE CYNOSURE. THIS LAST ONE DID NOT "GRAB" THE FAT LIKE THE OTHER TWO TIMES. ANY HELP OR DIRECTION WOULD BE APPRECIATED. THE DATES I HAVE FOR THE LAST TREATMENT WAS AT DR. (B)(6): (B)(6) 2018 AND (B)(6) 2018: THE 2ND WAS AT DR. (B)(6) I BELIEVE (B)(6) AND THE FIRST WAS DR. (B)(6) ALSO IN 2015 BUT I NEED TO VERIFY. ALL IN (B)(6). REFERENCE REPORTS MW5117442, MW5117443.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1164979 ORIGINAL COOL SCUPLT; COOL SCULPT BY ALLERGAN AND SCULPTURE CYNOSURE DERMAL COOLING PACK/VACUUM/MASSAGER OOK ALLERGAN/ABBVIE IRELAND NL B.V. BALLYTIVNAN

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Other CA++, VIT. D, VIT. B COMPLEX, FISH OIL, FIBER CAPSULES, MG+.| FELODOPINE 10 MG, TRIAMTERENE, VITAMINS.