BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN COOLSCULPTING SYSTEM

    MDR report key: 12751204 · Received November 4, 2021

    Report

    Report Number
    3007215625-2021-01922
    Event Type
    Injury
    Date Received
    November 4, 2021
    Date of Event
    October 6, 2021
    Report Date
    June 13, 2024
    Manufacturer
    ALLERGAN PLEASANTON
    Product Code
    OOK
    PMA / PMN Number
    K160259
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 3007215625-2021-01825-00.

    Additional Manufacturer Narrative · 0

    IT HAS BEEN IDENTIFIED THAT THIS RECORD, MRN 3007215625-2021-01922, IS A DUPLICATE OF MRN 3007215625-2021-01825. PLEASE SEE MRN 3007215625-2021-01825 FOR REPORTABLE EVENTS.

    Description of Event or Problem · 0

    CANCELED AS DUPLICATE OF INT-013048/CN-013314. I AM REACHING OUT BECAUSE I HAVE BEEN MADE AWARE THAT ACCOUNT: (B)(4) MIGHT HAVE A PAH CASE. THE ACCOUNT STATES THAT THEY REPORTED THE EVENT.

    Description of Event or Problem · 0

    PREVIOUS EMDR SUBMISSION NOTED PARADOXICAL HYPERPLASIA. UPON FURTHER REVIEW OF INFORMATION, ALLERGAN AESTHETICS HAS DETERMINED THAT THIS RECORD IS A DUPLICATE RECORD. PLEASE SEE MRN 3007215625-2021-01825 AS THE OPERATING RECORD RELATED TO THIS COMPLAINT.

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE COOLSCULPTING USER MANUAL, UNDER RARE ADVERSE EVENTS, PARADOXICAL ADIPOSE 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. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF AND WHEN ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    ALLERGAN AESTHETICS RECEIVED A REPORT THAT A PATIENT TREATED WITH COOLSCULPTING MAY HAVE DEVELOPED PARADOXICAL ADIPOSE HYPERPLASIA (PAH).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1652678 UNKNOWN COOLSCULPTING SYSTEM DERMAL COOLING PACK/VACUUM/MASSAGER OOK ALLERGAN PLEASANTON NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention