BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GN RESOUND

    MDR report key: 20319982 · Received September 27, 2024

    Report

    Report Number
    3005650109-2024-00077
    Event Type
    Malfunction
    Date Received
    September 27, 2024
    Date of Event
    August 26, 2024
    Report Date
    September 26, 2024
    Manufacturer
    GN HEARING A/S
    Product Code
    OSM
    UDI-DI
    05708296260638
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S REF# (B)(4). MANUFACTURER'S INVESTIGATION: TECHNICAL INVESTIGATION CONCLUDED: A DHR REVIEW HAVE BEEN COMPLETED. NO DEVIATION OR CHANGES WERE FOUND DURING MANUFACTURING OF THE DEVICE. CLINICAL CONCLUSION: IT HAS BEEN REPORTED THAT THE WAX GUARD GROMMET/BRASS RING HAS FALLEN OUT OF AN IN THE EAR HEARING AID. THE GROMMET DID NOT FALL OUT IN THE USER'S EAR CANAL. SINCE THE GROMMET FELL OUT, USER IS UNABLE TO USE A WAX GUARD ON THE DEVICE. THERE WAS NO HARM TO THE USER FOLLOWING THE INCIDENT. CLINICAL ASSESSMENT IS THAT THE EVENT DID NOT CAUSE HARM TO THE USER. 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: RISKS RELATED TO MECHANICAL DAMAGE / LOOSE PARTS 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 CONCLUDED: NO DEVICE INVESTIGATION PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. MANUFACTURER'S INVESTIGATION IS FINAL. THIS IS A COMBINED (INITIAL AND FINAL) REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE WAX GUARD GROMMET HAS FALLEN OUT OF AN IN THE EAR HEARING AID. THE GROMMET DID NOT FALL OUT INSIDE THE USER'S EAR CANAL. NOTHING WAS STUCK IN THE USER'S EAR, USER DID NOT SUSTAIN ANY HARM FROM THE EVENT. NO FURTHER FOLLOW UP IS AVAILABLE OR EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1684899 GN RESOUND HEARING AID, , AIR CONDUCTION WITH WIRELESS TECHNOLOGY OSM GN HEARING A/S RU9ITE-DWC-MP 05708296260638

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male