BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN COOLSCULPTING SYSTEM

    MDR report key: 12363505 · Received August 24, 2021

    Report

    Report Number
    3007215625-2021-01536
    Event Type
    Injury
    Date Received
    August 24, 2021
    Date of Event
    July 27, 2021
    Report Date
    May 15, 2024
    Manufacturer
    ALLERGAN PLEASANTON
    Product Code
    OOK
    PMA / PMN Number
    K160259
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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 3007215625-2021-01536-00.

    Additional Manufacturer Narrative · 0

    H11-: CORRECTED DATA: SUBSEQUENT TO THE SUBMISSION OF PREVIOUS MEDWATCH REPORT A CORRECTION WAS NOTED IN SECTION H10. CORRECTED STATEMENT IS THE FOLLOWING : SUBSEQUENT TO THE SUBMISSION OF INITIAL MEDWATCH, THIS REPORT HAS BEEN IDENTIFIED AS A DUPLICATE OF PREVIOUSLY SUBMITTED MEDWATCH REPORT OF 3007215625-2021-01544-00.

    Additional Manufacturer Narrative · 0

    THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING. 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 INCLUDED IN THE RISK MANAGEMENT FILES OF THE DEVICE BECAUSE IT IS A RISK THAT IS INHERENT TO THE USE CRYOLIPOLYSIS FOR LOCALIZED FAT REDUCTION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF AND WHEN ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 0

    DUPLICATE OF INT-010437/CN-009792. A CASE OF PARADOXICAL HYPERPLASIA WAS REPORTED TO THE MEDICAL INFORMATION TEAM.

    Description of Event or Problem · 0

    DUPLICATE OF (B)(4). A CASE OF PARADOXICAL HYPERPLASIA WAS REPORTED TO THE MEDICAL INFORMATION TEAM.

    Description of Event or Problem · 0

    DUPLICATE OF (B)(4). A CASE OF PARADOXICAL HYPERPLASIA WAS REPORTED TO THE MEDICAL INFORMATION TEAM.

    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 AESTHETICS RECEIVED A REPORT OF A PATIENT WHO WAS TREATED WITH COOLSCULPTING AND HAS DEVELOPED PARADOXICAL HYPERPLASIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1254985 UNKNOWN COOLSCULPTING SYSTEM DERMAL COOLING PACK/VACUUM/MASSAGER OOK ALLERGAN PLEASANTON NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention