BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHONAK

    MDR report key: 16962200 · Received May 19, 2023

    Report

    Report Number
    3005085999-2023-00007
    Event Type
    Injury
    Date Received
    May 19, 2023
    Date of Event
    April 8, 2023
    Report Date
    April 25, 2023
    Manufacturer
    SONOVA AG
    Product Code
    OSM
    UDI-DI
    07613389477818
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE RETURN OF THE DEVICE IS ANTICIPATED. HOWEVER DEVICE HAS NOT YET BEEN RECEIVED.

    Additional Manufacturer Narrative · 0

    THE SERVICE ORDER WHICH PRECEDED THE INCIDENT WAS ENTERED IN MARCH 2023. THE DEVICE DIAGNOSTIC CODES IDENTIFY THE ISSUES AS TOO WEAK OUTPUT RESPONSE AND DISTORTED SOUND. MOISTURE (SWEAT) EXPOSURE WAS NOTED BY DIAGNOSING TEAM, AS WELL AS A CLOGGED MICROPHONE. THE ELECTRONICS, HOUSING, RECEIVER, AND DOME WERE REPLACED IN SERVICE. THE UNIT WAS TESTED TO RELEASE CRITERIA ON MARCH 13, 2023 AND PASSED. THE DEVICE HAS BEEN DISCARDED AND WILL NOT BE AVAILABLE FOR ANALYSIS.

    Additional Manufacturer Narrative · 0

    AUGUST 3, 2023 THE HCP HAS CONFIRMED THAT THE HEARING AIDS WERE CHECKED AT THE CLINIC BEFORE THEY WERE MAILED TO THE PATIENT. NO FURTHER INFORMATION ABOUT THE CURRENT STATE OF THE PATIENT COULD BE OBTAINED. THIS IS THE FINAL REPORT. THE MANUFACTURER WILL CONDUCT FURTHER ASSESSMENT IF NEW INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    HCP REPORTED THAT AFTER THE HEARING AID CAME BACK FROM REPAIR IN MARCH 2023, THE PATIENT HEARD STATIC AND A LOUD SOUND IN THE LEFT HEARING AID. FOLLOWING THE EVENT THE PATIENT HAS EXPERIENCED A DECREASE IN HEARING, VERTIGO AND TINNITUS IN LEFT EAR. THE PATIENT SAW AN ENT ON (B)(6) 2023 AND WAS PRESCRIBED ORAL STEROIDS. THE PATIENT HAS DISCONTINUED THE USE OF THE HEARING AIDS AND RETURNED THEM TO HCP. THIS IS AN INITIAL REPORT. INVESTIGATION IS ONGOING. SUPPLEMENTAL REPORTS WILL BE SUBMITTED UPON AVAILABILITY OF FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670622 PHONAK AUDÉO L90-R OSM SONOVA AG 0500889P3 07613389477818

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other