BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOLTONE

    MDR report key: 23486787 · Received November 6, 2025

    Report

    Report Number
    8010720-2025-01781
    Event Type
    Injury
    Date Received
    November 6, 2025
    Date of Event
    September 7, 2025
    Report Date
    November 6, 2025
    Manufacturer
    ZIMMER MEDIZINSYSTEME GMBH
    Product Code
    NGX
    UDI-DI
    04053815076698
    PMA / PMN Number
    K251378
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ALLERGAN AESTHETICS RECEIVED A REPORT OF A PATIENT TREATED ABDOMEN ON (B)(6)2025 USING THE COOLTONE APPLICATOR AND PRESENTED WITH BLANCHING/REDNESS IMMEDIATELY AFTER TREATMENT AND THEN THE PATIENT PRESENTED WITH BLISTER. PRACTICE BELIEVES 2ND-3RD DEGREE BURN. LATER PROVIDER REPORTED OVERHEATING APPLICATOR AND "APPLICATOR IS WARPED, CRACKED, AND BULGING OUT". APPLICATOR WAS REPLACED. DEVICE REMAINS AT THE USER FACILITY.TEE REPORT WAS FORWARDED TO MANUFACTURER ZIMMER MEDIZINSYSTEME GMBH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2689307 COOLTONE STIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING NGX ZIMMER MEDIZINSYSTEME GMBH 5034 04053815076698

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Required Intervention| O