BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GN RESOUND

    MDR report key: 20210036 · Received September 13, 2024

    Report

    Report Number
    3005650109-2024-00070
    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). 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: COMPLETION OF DEVICE INVESTIGATION PERFORMED. TECHNICAL INVESTIGATION CONCLUDED: A DHR REVIEW HAVE BEEN COMPLETED. NO DEVIATION OR CHANGES WERE FOUND DURING MANUFACTURING OF THE DEVICE. VISUAL INSPECTION OF DEVICE SHOWED THE WAX GUARD FOR THE HEARING AIDS WERE IN PLACE AND DOES NOT APPEAR WORN OFF. THE CLINICAL INVESTIGATION CONCLUDED: CLINICAL EVALUATION OF THE EVENT: IT WAS REPORTED THAT THE RIGHT HEARING AID'S WAX GUARDS ON DO NOT STAY ON AND GROMMET APPEARS TO HAVE WORN OFF. IT WAS REPORTED THAT THE GROMMET THAT HOLDS THE WAX GUARD FELL OFF, BUT NOT IN THE USER'S EAR. THERE IS NO REPORTS OF HARM TO THE USER. NO CONTACT WITH AUTHORIZED MEDICAL PRACTITIONER AND NO MEDICAL TREATMENT REPORTED. DEVICE INVESTIGATION SHOWED THAT WAX GUARD FOR BOTH LEFT AND RIGHT HEARING AID WERE IN PLACE AND DOES NOT APPEAR WORN OFF. BASED ON THE THIS, THE CLINICAL CONCLUSION IS THAT NO ISSUE WAS FOUND AND THEREFORE NO HARM TO USER. CLINICAL EVALUATION ACCORDING TO CLIN EVAL PLAN&RPT,HA&TSG AND CLIN EVAL PLAN&RPT,OTHER ACC: HEARING AIDS NEED TO HAVE DETACHABLE SPARE PARTS AS WAX FILTERS. THEREFORE, ELIMINATING THE RISK OF A SPARE PARTS REMAINING IN THE EAR CANAL IS NOT POSSIBLE. A WAX FILTER CAN BECOME DETACHED AND REMAIN IN THE USER'S EAR CANAL WHEN THE HEARING AID IS REMOVED OR IF THE CERUSTOP BUSHING HAS BECOME DISLODGED FROM EXCESSIVE FORCE APPLIED DURING REPLACEMENTS OR CLEANING OF THE WAX FILTER. WITHOUT BUSHING, A REPLACED CERUSTOP IS NOT SECURE AND MAY FALL OUT IN THE EAR. THE WAX FILTER THEN CONSTITUTES A FOREIGN BODY IN THE EAR CANAL AND SHOULD BE REMOVED AS SOON AS POSSIBLE AS IT CAN POSE AN INFECTION RISK. THE HAZARD IS IDENTIFIED IN THE RISK ANALYSIS AND MITIGATED ON DEVICE DESIGN BY ENSURING THAT THE WAX FILTER CANNOT BE REMOVED WITHOUT A TOOL. THE USER GUIDE INCLUDES AN INSTRUCTION ON HOW TO REPLACE A WAX FILTER WITH A TOOL AND TO CONTACT THE HCP IF A FOREIGN OBJECT IS LOCATED IN THE EAR CANAL. RISK REGISTER REFERENCE: NO ISSUE WAS FOUND FOR THIS CASE. HOWEVER RISKS INVOLVING MECHANICAL DAMAGE ARE GENERALLY KNOWN, CONSIDERED IN THE RISK ANALYSIS, MITIGATED AND COMMUNICATED TO THE USER. THESE RISKS ARE DEEMED TO BE ACCEPTABLE. MANUFACTURER'S INVESTIGATION IS FINAL. THIS IS A FINAL REPORT.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S REF# (B)(4). 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

    ON (B)(6) 2024 (APPROXIMATE DATE) THE HEARING AID'S WAX GUARDS DO NOT STAY ON. IT HAD BEEN REPORTED THAT GROMMET APPEARS TO HAVE WORN OFF. THE GROMMET THAT HOLDS THE WAX GUARD FELL OFF, BUT NOT IN THE USER'S EAR. THEREFORE, NO HARM TO USER AND NO MEDICAL INTERVENTION NEEDED. NO FURTHER FOLLOW UP INFORMATION EXPECTED.

    Description of Event or Problem · 0

    ON 05-AUG-2024 (APPROXIMATE DATE) THE HEARING AID'S WAX GUARDS DO NOT STAY ON. IT HAD BEEN REPORTED THAT GROMMET APPEARS TO HAVE WORN OFF. THE GROMMET THAT HOLDS THE WAX GUARD FELL OFF, BUT NOT IN THE USER'S EAR. THEREFORE, NO HARM TO USER AND NO MEDICAL INTERVENTION NEEDED. NO FURTHER FOLLOW UP INFORMATION EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1564199 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