BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GN RESOUND

    MDR report key: 19717894 · Received July 11, 2024

    Report

    Report Number
    3005650109-2024-00061
    Event Type
    Malfunction
    Date Received
    July 11, 2024
    Date of Event
    June 10, 2024
    Report Date
    August 9, 2024
    Manufacturer
    GN HEARING A/S
    Product Code
    OSM
    UDI-DI
    05708296213351
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S REF# (B)(4). MANUFACTURER'S INVESTIGATION: TECHNICAL INVESTIGATION CONCLUDED: A DHR REVIEW HAS BEEN COMPLETED. NO DEVIATION OR CHANGES WERE FOUND DURING MANUFACTURING OF THE DEVICE, WAITING FOR PHOTO OF FAILED PRODUCT TO DO FURTHER INVESTIGATION MANUFACTURER'S INVESTIGATION IS ONGOING. A FINAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION THIS IS AN INITIAL REPORT. 09-AUG-2024: DESPITE ATTEMPTS, DEVICE HAS NOT BEEN RECEIVED BY MANUFACTURER. NO PHOTO RECEIVED. NO DEVICE INVESTIGATION POSSIBLE. THE CLINICAL INVESTIGATION CONCLUDED: CLINICAL EVALUATION ACCORDING TO 0378100 CLIN EVAL PLAN&RPT,OTHER ACC AND 0378040 CLIN EVAL PLAN&RPT,HA&TSG: THE CLINICAL EVALUATION FOR THE DEVICE FAMILY DOES EVALUATE OBJECTS SUCH AS WAX FILTER REMAINING IN THE EAR CANAL AFTER HEARING AID REMOVAL. 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 STATES TO CONTACT THE HCP IF A FOREIGN OBJECT IS IN THE EAR CANAL TO REDUCE THE POTENTIAL RISK OF HARM AS FAR AS POSSIBLE. THERE IS ALSO RISK THAT A HEARING AID'S EAR MOLD MAY BE DAMAGED AND POTENTIALLY BROKEN DUE TO UNEXPECTED EXTERNAL MECHANICAL FORCE BEYOND TYPICAL USE, AND THIS IS OF MOST CONCERN IN THE CONTEXT OF HARDER ACRYLIC MOLDS. SHOULD AN EARMOLD 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 EARMOLD 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. THE BRASS RING FELL OUT WHILE HCP WAS CHANGING THE WAX FILTER. AS THE WAX FILTERS CANNOT BE REMOVED WITHOUT A TOOL, IT IS EVALUATED VERY UNLIKELY THE BRASS RING WOULD BREAK IN THE EAR. 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 REFERENCE: RISK REG 0457500 TTM03. RISK ID: AC-TM-US2-17. SEVERITY 3. NO HARM HAPPENED, INCIDENT HAPPENED WHEN HCP TOOK DEVICE APART. KNOWN RISK. RISK CONTROLS ARE IN PLACE. DEEMED TO BE ACCEPTABLE. 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. THIS IS A FINAL REPORT.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S REF (B)(4). MANUFACTURER'S INVESTIGATION: TECHNICAL INVESTIGATION CONCLUDED: A DHR REVIEW HAS BEEN COMPLETED. NO DEVIATION OR CHANGES WERE FOUND DURING MANUFACTURING OF THE DEVICE, WAITING FOR PHOTO OF FAILED PRODUCT TO DO FURTHER INVESTIGATION 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

    DATE OF EVENT 10JUN2024. IT HAS BEEN REPORTED THAT THE BRASS RING ON THE EARMOULD, WHICH HOLDS THE WAX FILTER, HAS FALLEN OUT. IT HAPPENED WHEN THE HEARING CARE PROVIDER WAS CHANGING THE WAX FILTER, THE BRASS RING CAME OUT WITH THE FILTER, WHILE IN THE HAND OF THE HEARING CARE PROVIDER. THE EVENT HAS NOT CAUSED ANY HARM. FURTHER FOLLOW UP IS EXPECTED. 09-AUG-2024: NO FOLLOW UP RECEIVED.

    Description of Event or Problem · 0

    DATE OF EVENT 10JUN2024 IT HAS BEEN REPORTED THAT THE BRASS RING ON THE EARMOULD, WHICH HOLDS THE WAX FILTER, HAS FALLEN OUT. IT HAPPENED WHEN THE HEARING CARE PROVIDER WAS CHANGING THE WAX FILTER, THE BRASS RING CAME OUT WITH THE FILTER, WHILE IN THE HAND OF THE HEARING CARE PROVIDER. THE EVENT HAS NOT CAUSED ANY HARM. FURTHER FOLLOW UP IS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2385831 GN RESOUND HEARING AID, , AIR CONDUCTION WITH WIRELESS TECHNOLOGY OSM GN HEARING A/S 21655000 05708296213351

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male