BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK COOLSCULPTING

    MDR report key: 11872523 · Received May 24, 2021

    Report

    Report Number
    3007215625-2021-01313
    Event Type
    Injury
    Date Received
    May 24, 2021
    Date of Event
    June 1, 2017
    Report Date
    August 24, 2022
    Manufacturer
    ALLERGAN PLEASANTON
    Product Code
    OOK
    PMA / PMN Number
    K160259
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H11: CORRECTED DATA: SUBSEQUENT TO THE SUBMISSION OF INITIAL MEDWATCH, THIS REPORT HAS BEEN IDENTIFIED AS A DUPLICATE OF PREVIOUSLY SUBMITTED MEDWATCH REPORT OF 3007215625-2021-01315-00.

    Description of Event or Problem · 0

    A PATIENT REPORTED RECEIVING COOLSCULPTING TO UPPER ABDOMEN, LOWER ABDOMEN, UPPER BACK FAT, LOWER BACK FAT, HAS EXPERIENCED PARADOXICAL ADIPOSE HYPERPLASIA.

    Additional Manufacturer Narrative · 1

    THE FOLLOWING INFORMATION IS IN THE COOLSCULPTING USER MANUAL: PARADOXICAL HYPERPLASIA 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. INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    ALLERGAN RECEIVED A REPORT OF A PATIENT WHO RECEIVED COOLSCULPTING TREATMENTS ON (B)(6) 2016 - (B)(6) 2016 TO THE BILATERAL UPPER AND LOWER ABDOMEN, BILATERAL UPPER AND LOWER BACK FAT AREA AND BILATERAL BANANA ROLLS. THE PATIENT STATES 6 MONTHS AFTER TREATMENT, LARGE AREAS OF FAT DEVELOPED IN THE UPPER AND LOWER ABDOMEN AND UPPER AND LOWER BACK FAT AREAS. THE PATIENT HAS DIETED AND EXERCISED BUT NO MATTER WHAT SHE DID OR HOW MUCH WEIGHT WAS LOST THE FAT DID NOT GO AWAY. THE PATIENT WAS ASSESSED AT A PLASTIC SURGEONS OFFICE WHO TOLD HER THAT THE HARDENED FAT PACKETS WERE IN THE SHAPE OF THE APPLICATORS AND THAT SHE HAS PARADOXICAL HYPERPLASIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766150 UNK COOLSCULPTING DERMAL COOLING PACK/VACUUM/MASSAGER OOK ALLERGAN PLEASANTON NI

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Required Intervention