BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GN RESOUND

    MDR report key: 20309629 · Received September 26, 2024

    Report

    Report Number
    3005650109-2024-00075
    Event Type
    Malfunction
    Date Received
    September 26, 2024
    Date of Event
    August 27, 2024
    Report Date
    September 26, 2024
    Manufacturer
    GN HEARING A/S
    Product Code
    OSM
    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'S INVESTIGATION: TECHNICAL INVESTIGATION CONCLUDED: DEVICE HISTORY REGISTER REVIEW HAVE BEEN COMPLETED. NO DEVIATION OR CHANGES WERE FOUND DURING MANUFACTURING OF THE DEVICE. CLINICAL EVALUATION CONCLUSION: IT WAS REPORTED THAT ON THE (B)(6) 2024 THE USER WAS DRIVING AND ALL OF A SUDDEN, THE HEARING AID FELL OF THE USER'S EAR AND HALF THE RECEIVER ALONG WITH THE DOME STAYED IN THE USER'S EAR. SINCE THE USER WAS IN THE NEIGHBOURHOOD THE USER STOPPED BY AT THE HEARING CARE PROFESSIONAL'S (HCP) OFFICE TO HAVE THE RECEIVER REMOVED. THIS IS AN EXPERIENCED USER WHO HAS NOT HAD THIS ISSUE BEFORE. IT WAS REPORTED THAT THE EVENT DID NOT CAUSE HARM. THE HCP WILL BE ORDERING A NEW RECEIVER TO REPLACE THE BROKEN ONE. CLINICAL EVALUATION ACCORDING TO CLINICAL EVALUATION REPORT: 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 LOCATED 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. RISK ASSESSMENT COBLUSION: RISKS RELATED TO MECHANICAL FORCE ARE GENERALLY KNOWN, CONSIDERED IN THE RISK ANALYSIS, MITIGATED AND COMMUNICATED TO THE USER. THIS RISK IS DEEMED TO BE ACCEPTABLE. DEVICE INVESTIGATION CONCLUDED: PICTURE OF THE AFFECTED DEVICE EVALUATED TO DETERMINE APPLICABLE TRENDED CASE. TRENDED CASE DEVICE INVESTIGATION FINDINGS: ADHESIVE FAILURE MODE IS OBSERVED ON FAILED DEVICES. ADHESIVE TO ADHERENT INTERFACES DETACHED FROM EACH OTHER. ADHESIVE FAILURE MODES OCCUR DUE TO SEVERAL FACTORS SUCH AS INAPPROPRIATE ADHESIVE SELECTION, PURE SURFACE PREPARATION, AND EXPOSURE TO ENVIRONMENTAL FACTORS. ASSEMBLY LINES DO NOT OVERLAP TOTALLY BUT LEAVE OPEN GAPS, CREATING POCKETS FOR INGRESS AND RETENTION OF ADHESION DEGRADING MEDIA. USED ADHESIVE TECHNICAL SHEET SUGGESTS AVOIDING ADHESIVE USAGE IN CHLORINATED ENVIRONMENTS - WE HAVE BODY CONTACTS MANUFACTURER'S INVESTIGATION IS FINAL. THIS IS A COMBINED (INITIAL AND FINAL) REPORT.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT HEARING CARE PROFESSIONAL (HCP) REPORTS THAT A 78 YEAR OLD USER CAME IN TO SEE HIM WITH A LEFT RECEIVER THAT HAD BROKEN OFF AND STAYED IN HIS EAR WITH THE DOME ABOUT A HALF HOUR AGO. THE USER HAPPENED TO BE IN THE HCP'S NEIGHBORHOOD AND STOPPED BY IMMEDIATELY TO HAVE IT TAKEN OUT. THE RECEIVER WIRE WAS STILL ATTACHED TO THE HEARING AID BODY WITH PART OF THE RECEIVER ATTACHED TO IT. THE OTHER HALF OF THE RECEIVER AND DOME WERE IN THE USER'S EAR CANAL. THE HCP EXTRACTED THE BROKEN RECEIVER/DOME FROM THE USER'S EAR AND EXAMINED THE USER'S EAR. HE REPORTED THE OTOSCOPY TO BE NORMAL. NO SYMPTOMS OR EAR RELATED ISSUES WERE REPORTED BY THE USER TO THE HCP. NO FURTHER FOLLOW UP INFORMATION EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2263414 GN RESOUND HEARING AID, AIR-CONDUCTION WITH WIRELESS TECHNOLOGY OSM GN HEARING A/S NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male