BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GN RESOUND

    MDR report key: 20046554 · Received August 23, 2024

    Report

    Report Number
    3005650109-2024-00067
    Event Type
    Malfunction
    Date Received
    August 23, 2024
    Date of Event
    July 22, 2024
    Report Date
    September 20, 2024
    Manufacturer
    GN HEARING A/S
    Product Code
    OSM
    UDI-DI
    05708296219452
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S (B)(4). 22-AUG-2024: INVESTIGATION IS STILL IN PROGRESS; A FINAL REPORT WILL BE SUBMITTED UPON COMPLETION 19SEP2024: DEVICE HISTORY RECORD REVIEW: A DHR REVIEW HAVE BEEN COMPLETED. NO DEVIATION OR CHANGES WERE FOUND DURING MANUFACTURING OF THE DEVICE. CLINICAL EVALUATION: CLINICAL EVALUATION OF THE EVENT: IT WAS REPORTED THE USER HAD TO GO TO THE EMERGENCY ROOM BECAUSE A PIECE OF THE RECEIVER CAME LOOSE AND GOT STUCK IN EAR. NO FURTHER SYMPTOMS WERE REPORTED. CLINICAL CONCLUSION IS THAT THE DETACHED RECEIVER HAS NOT CAUSED HARM TO THE PATIENT AND NO MEDICAL TREATMENT WAS PRESCRIBED. CLINICAL EVALUATION ACCORDING TO CLIN EVAL PLAN&RPT, HA&TSG AND CLIN EVAL PLAN&RPT, OTHER ACC: 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 ASSESSMENT: RISK RELATED TO MECHANICAL DAMAGE ARE GENERALLY KNOWN MITIGATED AND COMMUNICATED TO THE USER. FOR THIS RISK, REFER TO CAPA. ALL RESULTING ACTIONS ARE CONTAINED WITHIN THE CAPA WHICH INCLUDES ASSESSMENT OF RISKS AND ASSOCIATED UPDATES. DEVICE INVESTIGATION AND TRENDED CASE INVESTIGATION CONCLUDED: BASED ON THE DEFECT PICTURE PROVIDED, THE GLUE APPEAR SUFFICIENT IN THE BOTTOM HOUSING. HOWEVER, INVESTIGATION ON TRENDED CASE HAS SHOWN THE GLUE MAY INTERACT WITH HUMAN EARWAX AND LOSE THE ADHESIVE PROPERTIES. THE MANUFACTURER'S INVESTIGATION IS COMPLETE. THIS IS A FINAL REPORT.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S REF (B)(4). 22-AUG-2024: INVESTIGATION IS STILL IN PROGRESS; A FINAL REPORT WILL BE SUBMITTED UPON COMPLETION

    Description of Event or Problem · 0

    22-AUG-2024: IT WAS REPORTED THAT A PIECE OF RECEIVER STUCK IN EAR. USER HAD TO GO TO THE EMERGENCY ROOM BECAUSE A PIECE OF THE RECEIVER CAME LOOSE AND GOT STUCK IN HIS EAR. IT WAS REPORTED THERE WAS NO HARM TO THE USER. NO FURTHER FOLLOW UP EXPECTED.

    Description of Event or Problem · 0

    ON (B)(6) 2024: IT WAS REPORTED THAT A PIECE OF RECEIVER STUCK IN EAR. USER HAD TO GO TO THE EMERGENCY ROOM BECAUSE A PIECE OF THE RECEIVER CAME LOOSE AND GOT STUCK IN HIS EAR. IT WAS REPORTED THERE WAS NO HARM TO THE USER. NO FURTHER FOLLOW UP EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1256955 GN RESOUND HEARING AID, AIR CONDUCTION WITH WIRELESS TECHNOLOGY OSM GN HEARING A/S 21385700 05708296219452

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention