BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOLSCULPTING SYSTEM

    MDR report key: 12080274 · Received June 28, 2021

    Report

    Report Number
    3007215625-2021-01406
    Event Type
    Injury
    Date Received
    June 28, 2021
    Date of Event
    May 25, 2021
    Report Date
    June 11, 2024
    Manufacturer
    ALLERGAN PLEASANTON
    Product Code
    OOK
    PMA / PMN Number
    K160259
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 3007215625-2021-01406-00.

    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 3007215625-2021-01389-00.

    Additional Manufacturer Narrative · 0

    CORRECTION DATA: B5, D1, D4, G1, H6.

    Description of Event or Problem · 0

    CASE IS DUPLICATE TO (B)(4). A TREATMENT PROVIDER REPORTED THEY HAVE A PATIENT WHO MAY HAVE DEVELOPED PARADOXICAL HYPERPLASIA POST COOLSCULPTING.

    Description of Event or Problem · 0

    CASE IS DUPLICATE TO CASE (B)(4). A TREATMENT PROVIDER REPORTED THEY HAVE A PATIENT WHO MAY HAVE DEVELOPED PARADOXICAL HYPERPLASIA POST COOLSCULPTING.

    Description of Event or Problem · 0

    THIS REPORT HAS BEEN IDENTIFIED AS A DUPLICATE OF PREVIOUSLY SUBMITTED MEDWATCH REPORT 3007215625-2021-01389-00.

    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 WAS TREATED WITH COOLSCULPTING AND MAY HAVE DEVELOPED PARADOXICAL HYPERPLASIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    975797 COOLSCULPTING SYSTEM DERMAL COOLING PACK/VACUUM/MASSAGER OOK ALLERGAN PLEASANTON NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention