BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GN RESOUND

    MDR report key: 16543787 · Received March 15, 2023

    Report

    Report Number
    3005650109-2023-00033
    Event Type
    Malfunction
    Date Received
    March 15, 2023
    Date of Event
    November 1, 2022
    Report Date
    March 14, 2023
    Manufacturer
    GN HEARING A/S
    Product Code
    OSM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S REFERENCE: SF (B)(4). TRENDED CASE DEVICE INVESTIGATION CONCLUSION: THE REAR HOUSING HAS TOO LITTLE GLUE TO KEEP HOUSING AND RECEIVER PARTS ADHERED TOGETHER, THEREBY CAUSING THE REAR HOUSING AND RECEIVER TO SEPARATE. CLINICAL ASSESSMENT CONCLUDED: 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 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. MANUFACTURER'S INVESTIGATION IS FINAL. THIS IS A COMBINED INITIAL AND FINAL REPORT

    Description of Event or Problem · 0

    ON AN UNKNOWN DATE IN (B)(6) 2022 THE RECEIVER BROKE DURING NORMAL USE WHEN REMOVING THE DEVICE FROM THE EAR. THE RECEIVER WAS LEFT IN THE MEMBER'S EAR AND NURSE (FAMILY MEMBER) REPORTEDLY REMOVED IT. NO HARM WAS CAUSED. NO FURTHER FOLLOW UP INFORMATION EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1051222 GN RESOUND HEARING AID, AIR-CONDUCTION WITH WIRELESS TECHNOLOGY OSM GN HEARING A/S UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention