BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GN RESOUND

    MDR report key: 20210226 · Received September 13, 2024

    Report

    Report Number
    3005650109-2024-00071
    Event Type
    Malfunction
    Date Received
    September 13, 2024
    Date of Event
    August 5, 2024
    Report Date
    November 27, 2024
    Manufacturer
    GN HEARING A/S
    Product Code
    OSM
    UDI-DI
    05708296260409
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S REF# (B)(4). MANUFACTURER'S INVESTIGATION: 12-SEP-2024: MANUFACTURER'S INVESTIGATION IS ONGOING. A FINAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION THIS IS AN INITIAL REPORT. 27-NOV-2024: VISUAL INSPECTION CONFIRM CHIPPED HEARING AID. TECHNICAL INVESTIGATION CONCLUDED: A DHR REVIEW HAVE BEEN COMPLETED. NO DEVIATION OR CHANGES WERE FOUND DURING MANUFACTURING OF THE DEVICE. THE CLINICAL INVESTIGATION CONCLUDED: CLINICAL CONCLUSION ON THE CASE IS THAT THERE WAS NO HARM TO THE USER. CLINICAL EVALUATION ACCORDING TO CLIN EVAL PLAN&RPT,HA&TSG: DESPITE TESTING AGAINST REQUIREMENTS FOR CONSTRUCTION, THERE IS STILL RISK THAT A HEARING AID MAY BE DAMAGED AND POTENTIALLY BROKEN DUE TO UNEXPECTED EXTERNAL MECHANICAL FORCE BEYOND TYPICAL USE. SHOULD A HEARING AID BREAK DUE TO MECHANICAL FORCE, THERE IS A POSSIBILITY THAT THE DAMAGE RESULTS IN THE CREATION OF EXPOSED SHARP EDGES. THESE SHARP EDGES COULD POTENTIALLY CAUSE HARM IN THE EAR CANAL, LIKELY ONLY SUPERFICIAL IN NATURE. IF THE HEARING AID IS ACCIDENTALLY DROPPED TO THE FLOOR AND THEN CRACKED OR SHATTERED INTO PIECES, IT IS EVALUATED AS VERY UNLIKELY THAT THE USERS MAY GET HARMED DUE TO SHARP CORNERS AND EDGES AS THE DAMAGE ITSELF IS OBVIOUS TO THE USERS. IT IS EVALUATED AS HIGHLY UNLIKELY THAT THE HEARING AID WOULD BREAK IN THE EAR UNLESS FORCE FROM AN EXTERNAL SOURCE IS PRESENT WHEN CONSIDERING THE SHELL THICKNESS OF THE HEARING AID. FURTHER, THE USER GUIDE INCLUDES A CAUTION NOT TO USE A BROKEN HEARING AID. RISK REGISTER REFERENCE: RISKS INVOLVING MECHANICAL DAMAGE ARE GENERALLY KNOWN, CONSIDERED IN THE RISK ANALYSIS, MITIGATED AND COMMUNICATED TO THE USER. THIS RISK IS DEEMED TO BE ACCEPTABLE. MANUFACTURER'S INVESTIGATION IS FINAL. THIS IS A FINAL REPORT.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S REF# (B)(4). MANUFACTURER'S INVESTIGATION: 12-SEP-2024: MANUFACTURER'S INVESTIGATION IS ONGOING. A FINAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION THIS IS AN INITIAL REPORT.

    Description of Event or Problem · 0

    ESTIMATED DATE OF INCIDENT (B)(6) 2024. IT WAS REPORTED HEARING AID CHIPPED AFTER BEING DROPPED. NO HARM TO USER. NO FURTHER FOLLOW UP IS AVAILABLE

    Description of Event or Problem · 0

    ESTIMATED DATE OF INCIDENT (B)(6) 2024. IT WAS REPORTED HEARING AID CHIPPED AFTER BEING DROPPED. NO HARM TO USER. NO FURTHER FOLLOW UP IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1106485 GN RESOUND HEARING AID, AIR CONDUCTION WITH WIRELESS TECHNOLOGY OSM GN HEARING A/S RU5ITC-DWC-MP 05708296260409

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female