BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GN RESOUND

    MDR report key: 20155936 · Received September 6, 2024

    Report

    Report Number
    3005650109-2024-00069
    Event Type
    Malfunction
    Date Received
    September 6, 2024
    Date of Event
    August 2, 2024
    Report Date
    September 2, 2024
    Manufacturer
    GN HEARING A/S
    Product Code
    OSM
    UDI-DI
    05708296174553
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF (B)(4). DHR REVIEW: A DHR REVIEW HAVE BEEN COMPLETED. NO DEVIATION OR CHANGES WERE FOUND DURING MANUFACTURING OF THE DEVICE. CLINICAL ASSESSMENT: CLINICAL EVALUATION OF THE EVENT: IT WAS REPORTED THAT THE USER COMPLAINED THAT THE WAX GUARD WOULD NOT STAY IN AND WHEN HEARING CARE PROFESSIONAL (HCP) LOOKED AT THE AID THEY NOTICED A CRACK. THE WAX GUARD DID NOT REQUIRE REMOVAL AND THE EVENT HAS NOT CAUSED HARM TO THE USER. THE CLINICAL EVALUATION IS THAT THE EVENT DID NOT CAUSE HARM TO THE USER. CLINICAL EVALUATION ACCORDING TO CLIN EVAL PLAN&RPT, HA&TSG AND CLIN EVAL PLAN&RPT, OTHER ACC: HEARING AIDS NEED TO HAVE DETACHABLE SPARE PARTS AS WAX FILTERS. THEREFORE, ELIMINATING THE RISK OF A SPARE PARTS REMAINING IN THE EAR CANAL IS NOT POSSIBLE. A WAX FILTER CAN BECOME DETACHED AND REMAIN IN THE USER'S EAR CANAL WHEN THE HEARING AID IS REMOVED OR IF THE CERUSTOP BUSHING HAS BECOME DISLODGED FROM EXCESSIVE FORCE APPLIED DURING REPLACEMENTS OR CLEANING OF THE WAX FILTER. WITHOUT BUSHING, A REPLACED CERUSTOP IS NOT SECURE AND MAY FALL OUT IN THE EAR. THE WAX FILTER THEN CONSTITUTES A FOREIGN BODY IN THE EAR CANAL AND SHOULD BE REMOVED AS SOON AS POSSIBLE AS IT CAN POSE AN INFECTION RISK. THE HAZARD IS IDENTIFIED IN THE RISK ANALYSIS AND MITIGATED ON DEVICE DESIGN BY ENSURING THAT THE WAX FILTER CANNOT BE REMOVED WITHOUT A TOOL. THE USER GUIDE INCLUDES AN INSTRUCTION ON HOW TO REPLACE A WAX FILTER WITH A TOOL AND TO CONTACT THE HCP IF A FOREIGN OBJECT IS LOCATED IN THE EAR CANAL. RISK ASSESSMENT: THE PRECISE CIRCUMSTANCES SURROUNDING THE ISSUE IS NOT KNOWN. RISKS RELATED TO MECHANICAL DAMAGE ARE GENERALLY KNOWN, CONSIDERED IN THE RISK ANALYSIS, MITIGATED AND COMMUNICATED TO THE USER. THIS RISK IS DEEMED TO BE OF AN ACCEPTABLE NATURE. DEVICE INVESTIGATION: DEVICE WAS REPAIRED AND RETURNED TO CUSTOMER BEFORE INVESTIGATION COULD TAKE PLACE. THIS IS A COMBINED (INITIAL AND FINAL) REPORT. MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE USER COMPLAINED THAT THE WAX GUARD WOULD NOT STAY IN AND WHEN HEARING CARE PROFESSIONAL (HCP) LOOKED AT THE AID THEY NOTICED A CRACK. THE WAX GUARD DID NOT REQUIRE REMOVAL AND THE EVENT HAS NOT CAUSED HARM TO THE USER. NO FURTHER FOLLOW UP IS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2074091 GN RESOUND HEARING AID, AIR CONDUCTION WITH WIRELESS TECHNOLOGY OSM GN HEARING A/S RE5ITC-DW-UP 05708296174553

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Male