BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOLTONE SYSTEM

    MDR report key: 23286628 · Received October 15, 2025

    Report

    Report Number
    3007215625-2025-00739
    Event Type
    Injury
    Date Received
    October 15, 2025
    Date of Event
    September 7, 2025
    Report Date
    October 13, 2025
    Manufacturer
    ZIMMER MEDIZINSYSTEME GMBH
    Product Code
    NGX
    PMA / PMN Number
    K192940
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION: D6A - IMPLANT DATE.

    Additional Manufacturer Narrative · 0

    THE COOLTONE USER MANUAL, UNDER WARNINGS, A THERMAL BURN ¿ THIRD DEGREE IS AN INJURY CAUSED BY EXPOSURE TO HEAT. THIRD DEGREE BURNS AFFECT THE DEEPER PART OF THE DERMIS AND HYPODERMIS OR SUBCUTANEOUS TISSUE, AND ARE CHARACTERIZED BY A WHITE, LEATHERY, RELATIVELY PAINLESS OR INSENSATE AREA. THERE MAY BE A CHARRED SPOT OR ESCHAR FORMATION.

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION: A6 - RACE. CORRECTION TO H11 FROM PRIOR SUBMISSION, THE COOLTONE USER MANUAL STATES MAXIMUM SURFACE TEMPERATURE OF THE APPLICATOR IS 43°C. IF THE MAXIMUM TEMPERATURE IS REACHED ALLOW THE SYSTEM TO COOL DOWN. PLACE THE APPLICATORS AS DEFINED IN THE CHAPTER ABOUT APPLICATOR PLACEMENT. DURING TREATMENT THE APPLICATOR WILL WARM UP, THIS IS NORMAL, IF THE PATIENT EXPERIENCES ANY DISCOMFORT DUE TO EXCESSIVE HEAT FROM THE APPLICATOR (>43°C) THEN DISCONTINUE TREATMENT. IF THE PATIENT EXPERIENCES ANY SYMPTOMS, THE OPERATOR MUST STOP TREATMENT IMMEDIATELY AND CONTACT THE APPROPRIATE PHYSICIAN.

    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.

    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.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193880 COOLTONE SYSTEM STIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING NGX ZIMMER MEDIZINSYSTEME GMBH NI

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Required Intervention