BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOLTONE SYSTEM

    MDR report key: 23845754 · Received December 18, 2025

    Report

    Report Number
    3007215625-2025-00883
    Event Type
    Injury
    Date Received
    December 18, 2025
    Date of Event
    November 24, 2025
    Report Date
    December 18, 2025
    Manufacturer
    ZIMMER MEDIZINSYSTEME GMBH
    Product Code
    NGX
    PMA / PMN Number
    K192940
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO ADDITIONAL INFORMATION WAS RECEIVED REGARDING ANY TREATMENT OR MEDICAL INTERVENTION REQUIRED FOR THE REPORTED EVENT. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT RECEIVED A COOTONE TREATMENT TO THE ABDOMEN AND PRESENTED WITH A "BURN" POST TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2242171 COOLTONE SYSTEM STIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING NGX ZIMMER MEDIZINSYSTEME GMBH NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention