BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOLTONE

    MDR report key: 23378729 · Received October 24, 2025

    Report

    Report Number
    8010720-2025-01774
    Event Type
    Injury
    Date Received
    October 24, 2025
    Date of Event
    August 19, 2025
    Report Date
    October 24, 2025
    Manufacturer
    ZIMMER MEDIZINSYSTEME GMBH
    Product Code
    NGX
    UDI-DI
    04053815076698
    PMA / PMN Number
    K251378
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    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. REPORTING DELAYED DUE TO COMPUTER PROBLEMS.

    Description of Event or Problem · 0

    ALLERGAN AESTHETICS RECEIVED A REPORT FROM A PATIENT WHO RECEIVED COOLTONE TREATMENT IN (B)(6) 2024, AND HAD SEVERE PAIN IN THE RIGHT THIGH AND STOPPED TREATMENT. REPORTER INDICATED THAT THE PATIENT WENT TO SEE A SPORTS MEDICINE DOCTOR AND WAS DIAGNOSED WITH TENDON TEAR FROM BONE. IT WAS REPORTED THAT THE PATIENT LOST ALL THE MUSCLE IN THE THIGHS AND BUTTOCKS BECAUSE OF THIS. THOUGH REQUESTED, ADDITIONAL EVENT INFORMATION WAS NOT PROVIDED BY THE PATIENT. ZIMMER MEDIZINSYSTEME GMBH WAS INFORMED BY ALLERGANAESTHETICS ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1505014 COOLTONE STIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING, PRODUCT CODE: NGX NGX ZIMMER MEDIZINSYSTEME GMBH 5034 N/A 04053815076698

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention