BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVALON US TRANSDUCER

    MDR report key: 23346855 · Received October 21, 2025

    Report

    Report Number
    9610816-2025-000979
    Event Type
    Injury
    Date Received
    October 21, 2025
    Date of Event
    October 15, 2025
    Report Date
    November 20, 2025
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
    Product Code
    HGL
    UDI-DI
    00884838002722
    PMA / PMN Number
    K140535
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A GOOD FAITH EFFORT ATTEMPT CONDUCTED REVEALED THAT A GEL WAS APPLIED TO THE SKIN PRIOR TO PLACEMENT OF THE TRANSDUCER ON THE LEFT LOWER ABDOMEN NEAR THE UMBILICUS. THE TRANSDUCER WAS IN PLACE FOR APPROXIMATELY 5 HOURS DURING THE COURSE OF LABOR AND DELIVERY BUT THE PATIENT DID NOT FEEL ANY DISCOMFORT AT THE TIME DUE TO AN EPIDURAL BEING PLACED. THE TRANSDUCER WAS COVERED BY A BLANKET. THE AFFECTED AREA CORRESPONDED TO THE BORDERS AND SHAPE OF THE TRANSDUCER. MULTIPLE BLISTERS WERE PRESENT AND ARRANGED IN A QUARTER CIRCLE PATTERN WITH LOOSENING OF THE SKIN IN SOME AREAS WITH GENERALIZED REDNESS ALSO NOTED ALONG THE BORDERS OF THE TRANSDUCER OUTLINE. THE SKIN REACTION WAS NOT OBSERVED IMMEDIATELY, BUT AT THE TIME THE PATIENT SHOWERED. THERE WAS NO MEDICAL INTERVENTION REQUIRED TO TREAT THE PATIENT AS THE BURN WAS EXPECTED TO HEAL COMPLETELY AND DID NOT RESULT IN PERMANENT DAMAGE AND THE PATIENT WAS DISCHARGED. THE CUSTOMER CONFIRMED OXYWIPES ARE USED TO DISINFECT THE TRANSDUCERS AND THEY ARE ALLOWED TO DRY COMPLETELY PRIOR TO PLACEMENT. THE PHILIPS REMOTE SUPPORT ENGINEER (RSE) TALKED TO THE CUSTOMER TO GATHER MORE INFORMATION ABOUT THE ALLEGED ISSUE AND TO HAVE THE CUSTOMER SENT PICTURES FROM THE BURN. THE TRANSDUCER WAS SENT BACK TO THE BU FOR CLOSER ANALYSIS. AFTER CLOSELY EXAMINING THE PICTURE AND THE DESCRIPTION OF THE BURN, IT APPEARS THE "CRESCENT-SHAPED" BURN-LIKE BLISTERING ON THE SKIN CLOSELY MATCHES THE SHAPE OF THE TPU. ANYTHING CAPABLE OF GENERATING HEAT IS NOT LOCATED BENEATH THE DOUBLE LAYER OF YELLOW TPU NEAR THE TRANSDUCER'S EDGE. INSTEAD, IT IS SITUATED BEHIND THE SMOOTH GRAY PLASTIC CENTER OF THE TRANSDUCER. CONSIDERING ALL THESE OBSERVATIONS, IT IS REASONABLE TO DETERMINE THAT THIS BURN INJURY DID NOT STEM FROM A THERMAL EFFECT. RATHER, IT SEEMS TO BE THE RESULT OF CHEMICAL IRRITATION, MOST LIKELY CAUSED BY RESIDUES FROM PREVIOUS CLEANING AND DISINFECTION PROCESSES. THERE IS NO VISIBLE DAMAGE TO THE APPEARANCE OF THE TRANSDUCER AND THERE WERE SENT BACK TO THE CUSTOMER. BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED THE BURN INJURY DID NOT RESULT FROM A THERMAL EFFECT, BUT FROM CHEMICAL IRRITATION, MOST LIKELY FROM RESIDUES FROM PRIOR CLEANING & DISINFECTION. THE REPORTED PROBLEM WAS NOT CONFIRMED. BASED ON THE INFORMATION AVAILABLE AND RESULTS OF ADDITIONAL ANALYSIS, NO FURTHER ACTION IS NECESSARY AT THIS TIME. THE DEVICE WAS CONFIRMED TO BE OPERATING PER SPECIFICATIONS AND NO FAILURE WAS IDENTIFIED. WE CAN CONCLUDE THAT THIS BURN INJURY DID NOT RESULT FROM A THERMAL EFFECT, BUT FROM A CHEMICAL IRRITATION, MOST LIKELY FROM RESIDUES FROM PRIOR CLEANING & DISINFECTION. THE CUSTOMER WAS PROVIDED THE WARNING STATEMENT FROM THE INSTRUCTIONS FOR USE (IFU). THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED. IFU WARNING: SKIN CONTACT: TO REDUCE THE RISK OF SKIN IRRITATIONS, DO NOT ALLOW A CLEANING OR DISINFECTING AGENT TO LEAVE RESIDUES ON ANY OF THE EQUIPMENT SURFACES - WIPE IT OFF WITH A CLOTH DAMPENED WITH WATER, AFTER ALLOWING THE APPROPRIATE TIME FOR THE AGENT TO WORK. FOLLOW THE SAFETY INSTRUCTIONS OF THE USED CLEANING OR DISINFECTION AGENT, ESPECIALLY REGARDING SKIN CONTACT.

    Additional Manufacturer Narrative · 0

    PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION CONCERNING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. D4: THE MANUFACTURING DATE FOR THE REPORTED DEVICE IS PRIOR TO 24SEPT2016 SO NO UDI REQUIRED. E1: REPORTING INSTITUTION PHONE#: (B)(6). E1: REPORTER PHONE#: (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TRANSDUCER LEFT SKIN WOUNDS WHERE THE MOST PRESSURE WAS APPLIED. THE SKIN WOUNDS APPEARED RED AND BLISTERED. NO OTHER CLINICAL INFORMATION OR MEDICAL INTERVENTION WAS REPORTED. BASED ON DETAILS AVAILABLE AT THE TIME OF THIS REVIEW, THERE IS INSUFFICIENT INFORMATION TO DETERMINE WHETHER THE REPORTED HARM MEETS CRITERIA FOR SERIOUS INJURY. THEREFORE, ADDITIONAL INFORMATION IS REQUESTED FOR FURTHER CLARIFICATION AND ASSESSMENT OF THE CUSTOMER¿S ALLEGED HARM(S).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2354658 AVALON US TRANSDUCER AVALON US TRANSDUCER HGL PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH AVALON US TRANSDUCER 00884838002722

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other