BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOLTONE

    MDR report key: 11189654 · Received January 18, 2021

    Report

    Report Number
    3007215625-2021-40001
    Event Type
    Injury
    Date Received
    January 18, 2021
    Date of Event
    March 9, 2020
    Report Date
    January 18, 2021
    Manufacturer
    ZIMMER MEDIZINSYSTEME GMBH
    Product Code
    NGX
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION CURRENTLY AVAILABLE TO THE DEVICE IMPORTER, ZELTIQ AESTHETICS, INC, A SERIOUS INJURY HAS OCCURRED. ALL INFORMATION OBTAINED THUS FAR WAS FORWARDED TO THE MANUFACTURER, ZIMMER (B)(4), THE MANUFACTURER OF THE DEVICE. IT IS THE RESPONSIBILITY OF ZIMMER (B)(4) TO PERFORM THE DEVICE INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION AND/OR RECEIPT OF ANY ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    ON (B)(6) 2020, ALLERGAN RECEIVED A REPORT THAT A PATIENT WAS TREATED TO THE BILATERAL INNER THIGHS WITH COOLTONE ON (B)(6) 2020 AND PRESENTED WITH A THIRD-DEGREE BURN TO THE RIGHT INNER THIGH. THE AREA WAS NOT COVERED WITH CLOTHING; HOWEVER, THE APPLICATOR WAS COVERED WITH A BONNET. THE SKIN/TISSUE WAS OPEN, AND THE BURN HEALED FROM THE INSIDE OUT. THE AREA NOW PRESENTS WITH A SCAR. THE DEVICE INVESTIGATION IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86148 COOLTONE STIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING NGX ZIMMER MEDIZINSYSTEME GMBH 5034 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other