BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOLSCULPTING

    MDR report key: 12787429 · Received November 9, 2021

    Report

    Report Number
    MW5105235
    Event Type
    Injury
    Date Received
    November 9, 2021
    Date of Event
    August 20, 2018
    Report Date
    November 5, 2021
    Manufacturer
    ZELTIQ AESTHETICS INC.
    Product Code
    OOK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT UNDERWENT COOLSCULPTING OF THE ABDOMEN, THE FLANKS, AND THE UPPER LATERAL BACK (BRA ROLLS). PATIENT EXPERIENCED ENLARGEMENT OF TWO OF THE TREATED AREAS (THE LOWER ABDOMEN AND THE BRA ROLLS). EXAMINATION BY ME IN (B)(6) 2021 REVEALED SIGNIFICANT ENLARGEMENT OF THOSE AREAS COMPARED WITH ADJACENT AREAS CONSISTENT WITH PARADOXICAL ADIPOSE HYPERPLASIA (PAH). PATIENT COMPLAINED THAT THE AREAS OF COOLSCULPTING GOT BIGGER WITHIN 3 MONTHS OF TREATMENT AND THAT SHE HAD TO GO UP IN CLOTHES SIZE BUT HER WEIGHT DID NOT CHANGE. SHE REQUIRED LIPOSUCTION OF THE BRA ROLLS, FLANKS AND LIPO-ABDOMINOPLASTY OF THE TORSO FOR CORRECTION OF HER PAH DEFORMITY. COOLSCULPTING WAS PERFORMED BY (B)(6). MY OFFICE ATTEMPTED TO GET MEDICAL RECORDS, BUT WAS TOLD THEY HAD NO RECORDS OR PICTURES. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1677598 COOLSCULPTING DERMAL COOLING PACK/VACUUM/MASSAGER OOK ZELTIQ AESTHETICS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female Required Intervention| S