BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GN HEARING

    MDR report key: 19925984 · Received August 7, 2024

    Report

    Report Number
    3005650109-2024-00065
    Event Type
    Malfunction
    Date Received
    August 7, 2024
    Date of Event
    June 18, 2024
    Report Date
    August 6, 2024
    Manufacturer
    GN HEARING A/S
    Product Code
    OSM
    UDI-DI
    05708296219469
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S REF(B)(4). MANUFACTURER'S INVESTIGATION CONCLUSION: TECHNICAL INVESTIGATION CONCLUDED: DEVICE HISTORY REGISTER REVIEW HAS BEEN COMPLETED. NO DEVIATION OR CHANGES WERE FOUND DURING MANUFACTURING OF THE DEVICE. TRENDED CASE DEVICE INVESTIGATION CONCLUSION: R&D CONCLUDES THAT THE REAR HOUSING HAS TOO LITTLE GLUE TO KEEP HOUSING AND RECEIVER PARTS ADHERED TOGETHER, THEREBY CAUSING THE REAR HOUSING AND RECEIVER TO SEPARATE. CAPA HAS BEEN INITIATED TO IMPROVE MANUFACTURING PROCESS. THE CLINICAL INVESTIGATION CONCLUDED: IT WAS REPORTED THAT THE RECEIVER HAS COME APART SEVERAL TIMES IN PATIENT'S EAR. METAL PART CAME OUT FROM PLASTIC PIECE. SAME INCIDENT HAS HAVE HAPPENED BEFORE. IT WAS REPORTED THAT PATIENT'S WIFE ASSISTED WITH THE REMOVAL THE FIRST TIME. NO THIRD-PARTY ASSISTANCE REQUIRED FOR THE REMOVAL. NO HARM REPORTED. HEARING CARE PROFESSIONAL REPLACED THE RECEIVER AND REPORTED INCIDENT TO THE MANUFACTURER. CLINICAL CONCLUSION IS THAT THE DETACHED RECEIVER HAS NOT CAUSED HARM TO THE PATIENT AND NO MEDICAL TREATMENT WAS PRESCRIBED. CLINICAL EVALUATION ACCORDING TO CLINICAL EVALUATION REPORT: THE CLINICAL EVALUATION FOR THE DEVICE FAMILY DOES EVALUATE RECEIVERS COMING LOOSE IN THE EAR CANAL. THIS IS IDENTIFIED IN THE RISK ANALYSIS AND MITIGATED THROUGH DEVICE DESIGN BY ENSURING A SUFFICIENT PULL FORCE (COMPLIANCE WITH IEC 60601-2-66). THE USER GUIDE STATES TO CONTACT THE HCP IF A FOREIGN OBJECT OR WAX IS LOCATED IN THE EAR CANAL TO REDUCE THE POTENTIAL RISK OF HARM AS FAR AS POSSIBLE. THERE ARE NO NEW CLINICAL ASPECTS (E.G. UNFORESEEN USE OR CLINICAL CONDITIONS) DISCOVERED FROM THIS EVENT. THEREFORE, IT IS CONCLUDED THAT THE CURRENT CLINICAL EVALUATION AND RISK/BENEFIT CONCLUSIONS HEREIN ARE SUFFICIENT. RISK REGISTER REFERENCE: NO PATIENT HARM. BASED ON THE INFORMATION PROVIDED THIS APPEARS TO BE A KNOWN RISK COVERED BY CAPA. ALL RESULTING ACTIONS ARE CONTAINED WITHIN THE CAPA WHICH INCLUDES ASSESSMENT OF RISKS AND ASSOCIATED UPDATES. MANUFACTURER'S INVESTIGATION IS FINAL. THIS IS A COMBINED (INITIAL AND FINAL) REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT RECEIVERS SEPARATING AT THE END WHERE THE TIP/DOME ATTACHED/GLUED ON. SAME INCIDENT HAS HAVE HAPPENED BEFORE IN (B)(6) 2023. IT WAS REPORTED THAT PATIENT'S WIFE ASSISTED WITH THE REMOVAL THE FIRST TIME. NO THIRD PARTY ASSISTANCE REQUIRED FOR THE REMOVAL. EVENT DID NOT CAUSE HARM. HEARING CARE PROFESSIONAL REPLACED THE RECEIVER AND REPORTED INCIDENT TO THE MANUFACTURER. NO PATIENT CONSEQUENCES. NO HARM OR INJURY REPORTED. NO FURTHER FOLLOW UP INFORMATION EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518862 GN HEARING HEARING AID, AIR-CONDUCTION WITH WIRELESS TECHNOLOGY OSM GN HEARING A/S 21385800 05708296219469

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Male