BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN COOLSCULPTING SYSTEM

    MDR report key: 13177111 · Received January 6, 2022

    Report

    Report Number
    3007215625-2022-00030
    Event Type
    Injury
    Date Received
    January 6, 2022
    Date of Event
    December 9, 2021
    Report Date
    June 3, 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

    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.

    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 3007215625-2022-00034-00.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: D1, D8, G1 AND H6.

    Description of Event or Problem · 0

    ALLERGAN AESTHETICS RECEIVED A REPORT OF A PATIENT WHO RECEIVED COOLSCULPTING TREATMENT AND MAY HAVE DEVELOPED PARADOXICAL ADIPOSE HYPERPLASIA.

    Description of Event or Problem · 0

    SUBJECT: [EXTERNAL] NEW PAH CLAIM-(B)(6), CASE OWNER: (B)(6). DESCRIPTION: 12/09/2021 -(B)(6) CAPITAL TECHNICAL SUPPORT SPECIALIST ALLERGAN FORWARDING TO CLINICAL. 2021-12-09 19:07:44Z ; , ZELTIQ. SUB TYPE: COOLSCULPTING. ACCOUNT NAME: (B)(6). CONTACT NAME: (B)(6). (B)(4). HI, I AM WRITING TO REPORT A NEW PAH CLAIM. WOULD YOU PLEASE OPEN A NEW CLAIM AND PROVIDE ME WITH A CF# AND PORTAL LINK FOR THE FOLLOWING CLAIMANT: (B)(6) THANKS! (B)(6). PLEASE REMEMBER THAT NOTHING HEREIN SHOULD BE CONSTRUED AS ADVICE ON ANY PARTICULAR CLIENT OR ISSUE, BUT RATHER AS A GENERAL OVERVIEW OF IDEAL IMAGE'S BEST PRACTICES. YOU SHOULD ALWAYS DIRECT QUESTIONS RELATING TO A SPECIFIC CLIENT OR SITUATION TO A MEDICAL OR NURSING PROFESSIONAL LICENSED IN YOUR STATE. THE INFORMATION CONTAINED IN THIS EMAIL MAY BE CONFIDENTIAL AND/OR LEGALLY PRIVILEGED. IT HAS BEEN SENT SOLELY FOR THE USE OF THE INTENDED RECIPIENT. IF YOU ARE NOT THE INTENDED RECIPIENT, YOU ARE HEREBY NOTIFIED THAT ANY UNAUTHORIZED REVIEW, USE, DISCLOSURE, DISSEMINATION, DISTRIBUTION, OR COPYING OF THIS COMMUNICATION, OR ANY OF ITS CONTENTS, IS STRICTLY PROHIBITED. IF YOU HAVE RECEIVED THIS MESSAGE IN ERROR, PLEASE REPLY TO SENDER THAT YOU HAVE RECEIVED THE MESSAGE IN ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    805666 UNKNOWN COOLSCULPTING SYSTEM DERMAL COOLING PACK/VACUUM/MASSAGER OOK ALLERGAN PLEASANTON NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention