BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVALON CL TOCO+ MP TRANSDUCER

    MDR report key: 23299875 · Received October 15, 2025

    Report

    Report Number
    9610816-2025-000952
    Event Type
    Malfunction
    Date Received
    October 15, 2025
    Date of Event
    September 24, 2025
    Report Date
    November 6, 2025
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
    Product Code
    HFM
    UDI-DI
    00884838034235
    PMA / PMN Number
    K140535
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    PATIENT INVOLVEMENT WAS REPORTED. THE PATIENT EXPERIENCED SKIN BLISTERING DURING USE. THE BLISTERING WAS NOT CLASSIFIED IN A BURN CATEGORY AND WERE EXPECTED TO HEAL COMPLETELY. INFORMATION PROVIDED INDICATED THE BLISTERING WAS RAISED, CLEAR, FLUID FILLED AND OCCURRED UNDER THE SMOOTH PART OF THE TRANSDUCER AND WAS SUPPORTED BY THE PROVIDED PICTURE. THE TRANSDUCER WAS IN PLACE APPROXIMATELY 3-4 HOURS. THE FSE CONFIRMED THAT THE UNIT MANAGER DID NOT TAKE ANY DETAILED INFORMATION OF THE EVENTS INCLUDING DEVICE SERIAL NUMBERS INVOLVED NOR WERE THE DEVICES ALLEGED IN THE INCIDENT SEQUESTERED FOR EVALUATION. THE INVESTIGATION DID FIND THAT THE CUSTOMER IS USING UNAPPROVED DISINFECTANT WIPES. ADDITIONALLY, THE CUSTOMER IS NOT FOLLOWING THE INSTRUCTIONS FOR USE (IFU) WHICH INSTRUCT THAT THE DEVICE BE WIPED OFF WITH A CLOTH DAMPENED WITH WATER, AFTER ALLOWING THE APPROPRIATE TIME FOR AGENT TO WORK. IT WAS CONFIRMED WITH THE UNIT MANAGER THAT THERE HAVE NOT BEEN ANY NEW CASES SINCE THE ORIGINAL CONFIRMED OCCURRENCES. WHILE A DEFINITIVE CAUSE HAS NOT BEEN DETERMINED, THE UNIT MANAGER ALSO AGREED THAT STAFF WILL START WIPING DOWN THE DEVICES WITH A WET CLOTH PER THE IFU INSTRUCTIONS AND TO SEQUESTER ANY OTHER DEVICES THAT CAUSE INJURY IN THE FUTURE AND TO CALL US BACK IF IT HAPPENS. SINCE THE DEVICES IN QUESTION WERE NOT SEQUESTERED AND WERE PUT BACK INTO CIRCULATION, A PROPER EVALUATION HAS NOT BEEN ABLE TO BE COMPLETED, THERE IS INSUFFICIENT INFORMATION TO BE ABLE TO DETERMINE CAUSE. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED.

    Description of Event or Problem · 0

    IT WAS REPORTED BLISTERS FORMED UNDER THE TRANSDUCER DURING USE. THE BLISTERING WAS RAISED, CLEAR, FLUID FILLED AND OCCURRED UNDER THE SMOOTH PART OF THE TRANSDUCER. THE TRANSDUCER WAS IN PLACE APPROXIMATELY 3-4 HOURS. THE PHYSICIAN WAS NOTIFIED BUT THE BLISTERING WAS NOT CLASSIFIED IN A BURN CATEGORY. THERE WAS NO TREATMENT PROVIDED, AND THE BURN WAS EXPECTED TO HEAL COMPLETELY. THE TRANSDUCER WAS MOVED TO ANOTHER AREA ON THE ABDOMEN, BUT IT WAS NOT NOTED BY THE USER IF THE TRANSDUCER WAS HOT TO THE TOUCH. THE SPECIFIC TRANSDUCER COULD NOT BE LOCATED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2021421 AVALON CL TOCO+ MP TRANSDUCER AVALON CABLELESS TOCO+ MP TRANSDUCER HFM PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH AVALON CABLELESS TOCO+ MP TRANSDUCER 00884838034235

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female