BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHONAK LYRIC4

    MDR report key: 22606862 · Received July 25, 2025

    Report

    Report Number
    3005085999-2025-00020
    Event Type
    Injury
    Date Received
    July 25, 2025
    Date of Event
    July 11, 2025
    Report Date
    July 16, 2025
    Manufacturer
    SONOVA AG
    Product Code
    ESD
    UDI-DI
    07613389603279
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER CONDUCTED AN INVESTIGATION. FOLLOW UP: IT IS SUSPECTED THAT THE INGESTION OF THE LYRIC DEVICE HAPPENED ON (B)(6) 2025. THE FAMILY TOOK THE PATIENT TO THE EMERGENCY DEPARTMENT OF THE LOCAL HOSPITAL. THE DEVICE WAS CONFIRMED INGESTED BY X-RAY. THE DOCTOR CONSULTED WITH A GI AND THEY AGREED THAT IT WAS OKAY TO LET THE DEVICE PASS AND NO MAJOR SURGERY WAS NEEDED. NO MEDICATION WAS PRESCRIBED. THE DEVICE PASSED THROUGH THE PATIENT'S SYSTEM AND THE PATIENT IS DOING WELL. A RELATIVE OF THE PATIENT SAID THAT THE PATIENT CONFUSED LYRIC WITH MEDICATION AND ACCIDENTLY SWALLOWED IT. THE PATIENT HAS NO COEXISTING CONDITIONS. MANUFACTURER ANALYSIS: THE INTENDED USE OF THE DEVICE REQUIRES IT TO BE SMALL IN SIZE, SO THAT IT CAN BE WORN IN THE EAR AND THE DEVICE CONTAINS BUILD-IN ZINC-AIR BATTERY, WHICH IS REQUIRED FOR DEVICE TO POWER UP AND FUNCTION. DUE TO THIS, DEVICE INGESTION IS A KNOWN AND INHERITED RISK OF THE DEVICE. PRODUCT'S RISK MANAGEMENT FILE CONTAINS A RISK ITEM ADDRESSING THIS HAZARD AND IMPLEMENTS WARNINGS. THE MANUFACTURER DEEMED THAT THE BENEFIT OF THE DEVICE OUTWEIGHS THE RISK. THE MANUFACTURER CHECKED DEVICE LABELLING. THE ACCOMPANYING USER GUIDE CONTAINS SEVERAL INFORMATION AND WARNINGS ABOUT THAT THE DEVICE CONTAINS ZINC-AIR BATTERY AND WARNS THE USER AGAINST SWALLOWING THE DEVICE AS WELL AS WHAT TO DO IF THE DEVICE WAS INGESTED INCL. A PHONE NUMBER TO THE 24-HOUR NATIONAL BATTERY INGESTION HOTLINE. THE PACKAGING INCLUDES A SYMBOL MEANING "DO NOT INGEST THE CONTENTS OF THE TWO PACKETS.". THE MANUFACTURER CHECKED FOR SIMILAR INCIDENTS AND THERE HAVE BEEN NO OTHER INSTANCES OF INGESTED LYRIC DEVICES RECORDED IN THE LAST 5 YEARS. THE MANUFACTURER WILL MONITOR FOR TRENDS. THIS IS COMBINED INITIAL & FINAL REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED TO THE MANUFACTURER THAT A PATIENT INGESTED LYRIC HEARING AID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2174642 PHONAK LYRIC4 HEARING AID, COMPLETELY-IN-CANAL ESD SONOVA AG 078-0067 07613389603279

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other