BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BELTONE

    MDR report key: 16766918 · Received April 19, 2023

    Report

    Report Number
    3005650109-2023-00052
    Event Type
    Malfunction
    Date Received
    April 19, 2023
    Date of Event
    March 1, 2023
    Report Date
    May 16, 2023
    Manufacturer
    GN HEARING A/S
    Product Code
    OSM
    UDI-DI
    05708296208043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S REF# (B)(4). MANUFACTURER HAS NOT RECEIVED THE DEVICE YET. INVESTIGATION IS STILL IN PROGRESS; A FINAL REPORT WILL BE SUBMITTED UPON COMPLETION.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S REF# (B)(4). MANUFACTURER HAS NOT RECEIVED THE DEVICE YET. INVESTIGATION IS STILL IN PROGRESS; A FINAL REPORT WILL BE SUBMITTED UPON COMPLETION. 16-MAY-2023: THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. THEREFORE, NO DEVICE INVESTIGATION POSSIBLE. TECHNICAL INVESTIGATION CONCLUDED: A DEVICE HISTORY RECORD REVIEW HAS BEEN COMPLETED. NO DEVIATION OR CHANGES WERE FOUND DURING THE MANUFACTURING OF THE DEVICE. THE CLINICAL INVESTIGATION CONCLUDED: CLINICAL EVALUATION FOR THE DEVICE FAMILY EVALUATES THE RISK OF LEAKAGE FROM BATTERIES. BATTERY LEAKAGE CAN IN SOME CASES BE PREVENTED IF THE HEARING AIDS ARE DRIED OUT AFTER USE BY OPENING THE BATTERY DOOR. FURTHER, BATTERIES THAT ARE EXPIRED ARE MORE LIKELY TO LEAK. THE USER GUIDE INCLUDES RECOMMENDATIONS ON BOTH HEARING AID DRYING AND ONLY TO USE BATTERIES WITH A REMAINING SHELF LIFE OF ONE YEAR OR MORE. THE USER GUIDE CONTAINS INFORMATION ONLY TO USE QUALITY BATTERIES AS WELL AS RINSING WITH LUKEWARM WATER IF EXPOSED TO BATTERY LEAKAGE. 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 CONCLUSION: 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 CONSIDERED AS A SINGLE INCIDENT AND WILL BE INCLUDED IN REGULAR TRENDING. NO ACTIONS HAVE BEEN INITIATED BASED ON THIS INDIVIDUAL EVENT. MANUFACTURER'S INVESTIGATION IS FINAL. THIS IS A FINAL REPORT.

    Description of Event or Problem · 0

    18-APR-2023: IT WAS REPORTED: "UNSURE IF THE BATTERY ACID HAS CAUSED ANY INTERNAL CIRCUIT DAMAGE". USER DIDN'T PUT AID ON AS NOTICED SOMETHING WAS LEAKING. NO HARM TO USER WAS REPORTED.

    Description of Event or Problem · 0

    18-APR-2023: IT WAS REPORTED: "UNSURE IF THE BATTERY ACID HAS CAUSED ANY INTERNAL CIRCUIT DAMAGE". USER DIDN'T PUT AID ON AS NOTICED SOMETHING WAS LEAKING. NO HARM TO USER WAS REPORTED. (B)(6) 2023: DISPOSABLE BATTERIES WERE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1548172 BELTONE HEARING AID, AIR-CONDUCTION WITH WIRELESS TECHNOLOGY OSM GN HEARING A/S RLY2ITC-DW-MP 05708296208043

    Patients

    Seq Age Sex Outcome Treatment
    1 Female