BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHONAK

    MDR report key: 16947752 · Received May 17, 2023

    Report

    Report Number
    3005085999-2023-00005
    Event Type
    Injury
    Date Received
    May 17, 2023
    Report Date
    April 20, 2023
    Manufacturer
    SONOVA AG
    Product Code
    OSM
    UDI-DI
    07613389358513
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE HCP WILL NOT PROVIDE ANY FURTHER INFORMATION ON THE CASE AND THE DEVICES WILL NOT BE RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORDS DO NOT SHOW ANY ABNORMALITIES IN PRODUCTION PROCESS. THE DEVICES HAVE SUCCESSFULLY PASSED ALL THE PRESCRIBED QUALITY TESTS. THIS IS THE FINAL REPORT.

    Additional Manufacturer Narrative · 0

    THE PATIENT HAS RECOVERED AND RETURNED TO USING HEARING AIDS. THE DEVICE HAS BEEN REQUESTED TO BE RETURNED TO SONOVA FACILITY FOR FURTHER ANALYSIS. BUT IT HAS NOT BEEN YET RETURNED.

    Description of Event or Problem · 0

    HCP REPORTED THAT THE PATIENT EXPERIENCED DIZZINESS TWO DAYS AFTER COMMENCING THE USE OF THE PHONAK NAIDA P30-PR HEARING AIDS, AND HAS BEEN HOSPITALIZED DUE TO THE SYMPTOMS. REPORTEDLY,THE HOSPITAL STATED THAT THE CAUSE OF THE ISSUE IS LIKELY TO BE OVER AMPLIFIED SOUND FROM THE HEARING AIDS. THE PATIENT DID NOT RETURN TO USING THE REPORTED HEARING AIDS AND HAS BEEN RE-FIT WITH RIC DEVICES IN (B)(6) 2023. PATIENT HAS HAD NO COMPLAINTS OF DIZZINESS SINCE THE ORIGINAL EPISODE. THIS IS AN INITIAL REPORT. THE INVESTIGATION IS ONGOING. SUPPLEMENTAL REPORTS WILL BE SUBMITTED UPON AVAILABILITY OF FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542002 PHONAK NAIDA P30-PR OSM SONOVA AG 0500807H0 07613389358513

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other