BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK COOLSCULPTING

    MDR report key: 15404768 · Received September 12, 2022

    Report

    Report Number
    3007215625-2022-01383
    Event Type
    Injury
    Date Received
    September 12, 2022
    Date of Event
    July 13, 2020
    Report Date
    September 12, 2022
    Manufacturer
    ALLERGAN PLEASANTON
    Product Code
    OOK
    PMA / PMN Number
    K160259
    Removal / Correction Number
    90331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF AND WHEN ADDITIONAL INFORMATION IS OBTAINED. ZELTIQ INITIATED A VOLUNTARY DISCONTINUATION AND RECALL OF PARALLEL PLATE APPLICATORS FOR THE COOLSCULPTING® SYSTEM DUE TO THE OBSERVANCE OF AN INCREASED RATE OF PARADOXICAL HYPERPLASIA (PH) ASSOCIATED WITH THESE APPLICATORS DURING A RECENT ANALYSIS OF DATA FROM THE 2019-2021 TIMEFRAME. THESE APPLICATORS ARE SOLD UNDER THE BRAND NAMES COOLCORE, COOLCURVE, COOLCURVE+, COOLMAX AND COOLFIT.

    Additional Manufacturer Narrative · 0

    H11: CORRECTION - UPON FURTHER REVIEW OF THE REPORTED EVENT, THIS REPORT HAS BEEN IDENTIFIED AS A DUPLICATE OF PREVIOUSLY SUBMITTED MEDWATCH REPORT 3007215625-2022-01416-00.

    Description of Event or Problem · 0

    ALLERGAN AESTHETICS RECEIVED A REPORT OF A PATIENT TREATED LOWER ABDOMEN WITH COOLSCULPTING COOLADVANTAGE PLUS COOLCORE DEVELOPED PARADOXICAL HYPERPLASIA (PAH/PH). DIAGNOSED ON (B)(6) 2022 WITH PAH BY MEDICAL DOCTOR.

    Description of Event or Problem · 0

    UPON FURTHER REVIEW OF THE REPORTED EVENT, THIS REPORT HAS BEEN IDENTIFIED AS A DUPLICATE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2214378 UNK COOLSCULPTING DERMAL COOLING PACK/VACUUM/MASSAGER OOK ALLERGAN PLEASANTON NI

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Female Required Intervention