BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHONAK

    MDR report key: 17363911 · Received July 20, 2023

    Report

    Report Number
    3005085999-2023-00008
    Event Type
    Injury
    Date Received
    July 20, 2023
    Report Date
    June 21, 2023
    Manufacturer
    SONOVA AG
    Product Code
    ESD
    UDI-DI
    07613389452044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THREE DOCUMENTED FOLLOW UP ATTEMPTS HAVE BEEN MADE TO OBTAIN FURTHER INFORMATION ON THE CASE. NO FURTHER INFORMATION COULD BE OBTAINED. THE INCIDENT IS ATTRIBUTED TO A USE ERROR. THERE IS NO INDICATION OF DETERIORATION IN THE DEVICE PERFORMANCE. THE RISK OF INGESTION IS AN INHERENT RISK OF THE DEVICE AND IS EVALUATED IN THE DEVICE RISK FILE. THE CASE WILL BE RE-ASSESSED IN CASE FURTHER INFORMATION BECOMES AVAILABLE. SIMILAR EVENTS WILL BE FURTHER MONITORED FOR TRENDS. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 0

    HEARING AID DISPENSER HAS REPORTED THAT A PATIENT HAS INGESTED A HEARING AID WITH A ZINC-AIR BATTERY INSIDE. IT IS UNKNOWN IF THE RIGHT OR THE LEFT HEARING AID HAS BEEN INGESTED. FOLLOW UP IS ONGOING TO CONFIRM THE PATIENT OUTCOME AND OBTAIN FURTHER INFORMATION ABOUT THE EVENT. SUPPLEMENTARY REPORT WILL BE FILED UPON AVAILABILITY OF FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734574 PHONAK VIRTO P50-10 NW O ESD SONOVA AG 063050801 07613389452044

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other