BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GN HEARING

    MDR report key: 16909291 · Received May 11, 2023

    Report

    Report Number
    3005650109-2023-00063
    Event Type
    Malfunction
    Date Received
    May 11, 2023
    Date of Event
    April 11, 2023
    Report Date
    May 12, 2023
    Manufacturer
    GN HEARING A/S
    Product Code
    OSM
    UDI-DI
    05708296254880
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S REF: (B)(4). IT HAS BEEN REPORTED THAT RECEIVER BROKE A TIP(BLUE TIP WITH DOME ATTACHED REMAINED IN HIS EAR CANAL). THE PATIENT DID SEEK MEDICAL HELP TO REMOVE THE OBJECT FROM THE EAR. NO FURTHER SYMPTOMS WERE REPORTED. CLINICAL CONCLUSION IS THAT THE THIS HAS NOT CAUSED HARM TO THE PATIENT AND NO MEDICAL TREATMENT WAS PRESCRIBED. THE CLINICAL INVESTIGATION CONCLUDED THAT THE CURRENT CLINICAL EVALUATION AND RISK/BENEFIT CONCLUSIONS HEREIN ARE SUFFICIENT. TECHNICAL INVESTIGATION FROM THE TRENDED CASE STATES THAT THERE IS LESS GLUE AND THIS IS FURTHER IMPACTED BY EAR WAX. RISK ASSESSMENT: THE RISK IS DEEMED ACCEPTABLE. A DHR (L2326264172) REVIEW HAVE BEEN COMPLETED. NO DEVIATION OR CHANGES WERE FOUND DURING MANUFACTURING OF THE DEVICE. THIS IS A COMBINED INITIAL AND FINAL REPORT. MANUFACTURER'S INVESTIGATION IS FINAL.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT RECEIVER BROKE A TIP(BLUE TIP WITH DOME ATTACHED REMAINED IN HIS EAR CANAL). THIS HAPPENED FOR THE FIRST TIME. THE PATIENT DID SEEK MEDICAL HELP TO REMOVE THE OBJECT FROM THE EAR. NO FURTHER SYMPTOMS WERE REPORTED. NO HARM CAUSED AND NO TREATMENT NEEDED. THE PATIENT HAS RECEIVED NEW REPLACEMENT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1166067 GN HEARING HEARING AID, AIR-CONDUCTION WITH WIRELESS TECHNOLOGY, PRESCRIPTION OSM GN HEARING A/S 22420174 05708296254880

    Patients

    Seq Age Sex Outcome Treatment
    1 Male