BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REXTON

    MDR report key: 18930665 · Received March 19, 2024

    Report

    Report Number
    3005019184-2024-00020
    Event Type
    Injury
    Date Received
    March 19, 2024
    Date of Event
    June 25, 2023
    Report Date
    March 19, 2024
    Manufacturer
    SIVANTOS GMBH
    Product Code
    OSM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    WE WERE MADE AWARE THAT OUR ELECTRONIC SUBMISSIONS FAILED AND WERE NOT RECEIVED BY FDA. A CAPA WAS OPENED TO ADDRESS THIS ISSUE AND THIS REPORT IS BEING ELECTRONICALLY RESUBMITTED TO CORRECT THE ERROR OF THE FIRST FAILED SUBMISSIONS. (SUBMITTED ON 08/10/2023) DISTRIBUTOR, IMPORTER AND MANUFACTURER ARE UNDER THE WS AUDIOLOGY COMPLIANCE SYSTEM.

    Description of Event or Problem · 0

    IN THIS EVENT, THE END USER HAD EXPERIENCED RECURRING ALLERGIC REACTIONS AFTER WEARING THEIR HEARING AID. USER REPORTED HAVING A LATEX AND NICKEL ALLERGY. THE INITIAL COMPLAINT FROM THE USER WAS MULTIPLE ALLERGIC REACTIONS, WHICH RESULTED IN SEVERAL EAR INFECTIONS FROM WEARING THE HEARING AID. PER THE HEALTH CARE PROFESSIONAL, "BOTH EARS ARE CLEARLY INFECTED, AND USER MENTIONED THAT SHE WILL SEE AN EAR SPECIALIST AT THE END OF THIS MONTH. USER HAS BEEN ADVISED NOT TO WEAR ANY HEARING AIDS UNTIL THE INFECTION HAS CLEARED UP." OUR DEVICE DOES NOT CONTAIN LATEX, HOWEVER CONTAINS STAINLESS STEEL WITH A LOW LEVEL OF NICKEL. THE STAINLESS STEEL COMPONENT IS COVERED BY A SLEEVE THAT DOES NOT DIRECTLY COME IN CONTACT TO CUSTOMER'S SKIN. RESULTS OF TECHNICAL INVESTIGATION: FINDINGS SUPPORT THERE IS NO POSSIBILTY OF AN ALLERGIC REACTION TO THE NICKEL/STAINLESS STEEL DUE TO THE FACT THAT THE SLEEVE COVERS THE METAL WHICH PREVENTS DIRECT CONTACT TO THE SKIN. HOWEVER, THE INVESTIGATORS SUSPECT THAT THE INFECTION IS EXPECTED TO NOT BE A RESULT OF AN ALLERGIC REACTION, BUT MAY BE SUPPORTED BY CLOSING OF EAR CANAL BY THE HEARING AIDS LEADING TO BACTERIUM, HUMIDITY AND MOLD BUILDUP WHICH CAN CAUSE OTITIS. MATERIALS WHICH ARE IN CONTACT WITH CUSTOMERS SKIN WERE TESTED FOR THEIR BIOCOMPATIBILITY ACCORDING TO EN ISO 10993-1:2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2553714 REXTON M-CORE IX-CIC 80 OSM SIVANTOS GMBH 10990778

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention