BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GN RESOUND

    MDR report key: 17037084 · Received June 1, 2023

    Report

    Report Number
    3005650109-2023-00074
    Event Type
    Injury
    Date Received
    June 1, 2023
    Date of Event
    May 1, 2023
    Report Date
    May 31, 2023
    Manufacturer
    GN HEARING A/S
    Product Code
    OSM
    UDI-DI
    05708296088546
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S REFERENCE: (B)(4). TECHNICAL INVESTIGATION CONCLUDED: A DHR REVIEW HAVE BEEN COMPLETED. NO DEVIATION OR CHANGES WERE FOUND DURING MANUFACTURING OF THE DEVICE. PICTURES OF THE DEVICE SET-UP WAS OBTAINED AND WAS REVIEWED BY AN AUDIOLOGIST WHO CONFIRMED THAT THE SPORTSLOCK WAS NOT INSTALLED ALL THE WAY ON THE RECEIVER. THIS CAN THEN LEAD TO THE DOME NOT BEING FULLY SECURED AND MAY LEAD TO THE DOME FALLING OFF. THE CLINICAL INVESTIGATION CONCLUDED:IT HAS BEEN REPORTED THAT THE PATIENT HAD A DOME LODGED IN EAR. IT LOOKS LIKE THE SPORTS LOCK WAS INCORRECTLY POSITIONED CAUSING THE DOME TO DISLODGE IN EAR. THE PATIENT WENT TO ER FOR REMOVAL OF DOME. NO FURTHER SYMPTOMS WERE REPORTED. CLINICAL CONCLUSION IS THAT THE THIS HAS NOT CAUSED HARM TO THE PATIENT AND NO MEDICAL TREATMENT WAS PRESCRIBED. CLINICAL EVALUATION: HEARING AIDS NEED TO HAVE DETACHABLE SPARE PARTS SUCH AS DOMES. THEREFORE, ELIMINATING THE RISK OF A SPARE PARTS REMAINING IN THE EAR CANAL IS NOT POSSIBLE. THE CLINICAL EVALUATION FOR THE DEVICE FAMILY DOES EVALUATE DOMES 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. THE RISK ANALYSIS FURTHER ADDRESSES THIS HAZARD. IT IS KNOWN THAT THE RISK OF AN INFECTION IS MINIMAL IF THE DOME IS REMOVED IN A TIMELY MANNER. 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 CONCLUDED: THE RESIDUAL RISK AFTER THE RISK CONTROL MEASURE(S) IS ACCEPTABLE. NO NEW HAZARDOUS SITUATIONS REVEALED AND NO NEED TO UPDATE THE RISK REGISTER. THIS CASE IS BEING REPORTED SINCE PATIENT REQUIRED A VISIT TO THE ER TO REMOVE THE DOME. THIS IS A FINAL REPORT.

    Description of Event or Problem · 0

    ON (B)(6) 2023, PATIENT STATED DOME BECAME LODGED IN HIS EAR AND WAS STIL LODGED IN HIS EAR WHEN CUSTOMER SERVICE AGENT CALLED TO ASK FOLLOW-UP QUESTIONS ((B)(6) 2023). PATIENT DID NOT DESCRIBE ANY OTHER SYMPTOMS OR HARM. PATIENT STATED THAT WERE WAITING TO SEE IF DOME WILL WORK ITS WAY OUT. PATIENT HAD FITTED IN NEW DOMES BY THEMSELVES 3+ WEEKS EARLIER. ON AN UNKNOWN DATE, PATIENT WENT TO ER TO REMOVE DOME FROM HIS EAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1683086 GN RESOUND HEARING AID, AIR-CONDUCTION WITH WIRELESS TECHNOLOGY OSM GN HEARING A/S 20574204 05708296088546

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention