BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVALON CL FETAL & MATERNAL POD

    MDR report key: 23826566 · Received December 17, 2025

    Report

    Report Number
    9610816-2025-001240
    Event Type
    Injury
    Date Received
    December 17, 2025
    Date of Event
    November 19, 2025
    Report Date
    February 9, 2026
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
    Product Code
    HFM
    UDI-DI
    00884838068179
    PMA / PMN Number
    K140535
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL REVIEW OF THE RECORD WAS PERFORMED, REVEALING THE ORIGINAL CUSTOMER FEEDBACK FORM CATEGORIZED THE HARM AS 'TEMPORARY OR REVERSIBLE HARM TO A PERSON (NOT REQUIRING ADDITIONAL MEDICAL INTERVENTION)'. BASED ON THIS INFORMATION, THE HARM WAS NOT LIFE THREATENING, DID NOT RESULT IN PERMANENT DAMAGE/IMPAIRMENT, AND DID NOT REQUIRE MEDICAL OR SURGICAL INTERVENTION; THEREFORE, THE EVENT DOES NOT MEET CRITERIA FOR SERIOUS INJURY. NO ANALYSIS WAS PERFORMED. THE MIDWIFE WAS TRAINED ON HOW TO APPLY THE PATCH TO THE MOTHER. ATTEMPTS WERE MADE TO REACH THE CUSTOMER FOR ADDITIONAL INFORMATION HOWEVER, THE CUSTOMER DID NOT RESPOND. THE INVESTIGATION FOUND THAT THE PRODUCT WAS CONFIRMED TO BE OPERATING PER SPECIFICATIONS, AND THE CAUSE OF THE REPORTED PROBLEM WAS THAT THE CUSTOMER REQUIRED TRAINING. THE ISSUE WAS RESOLVED BY TRAINING ON HOW TO APPLY THE PATCH TO THE MOTHER. A REVIEW OF THE SERVICE HISTORY FOR THIS DEVICE SHOWS THE PROBLEM HAS NOT BEEN REPORTED AGAIN FOR THIS DEVICE.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT DEVELOPED A SKIN REACTION UNDER THE PATCHES OF THE BELTLESS SOLUTION. PER THE PROVIDED PICTURE, A CRUST OR SCAB FORMED IN A CIRCULAR PATTERN WHERE THE PATCHES WERE APPLIED. NO OTHER CLINICAL INFORMATION OR MEDICAL INTERVENTION WAS REPORTED; THEREFORE, GOOD FAITH EFFORTS ARE BEING PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2040826 AVALON CL FETAL & MATERNAL POD MONITOR, UTERINE CONTRACTION, EXTERNAL (FOR USE IN CLINIC) HFM PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH AVALON CL FETAL & MATERNAL POD 00884838068179

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other