BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WIDEX

    MDR report key: 19341050 · Received May 17, 2024

    Report

    Report Number
    3013294311-2024-00035
    Event Type
    Injury
    Date Received
    May 17, 2024
    Date of Event
    April 14, 2024
    Report Date
    August 20, 2024
    Manufacturer
    INTEGRATED MICRO-ELECTRONICS INC.
    Product Code
    OSM
    UDI-DI
    05706069923254
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CONDITION OF THE BATTERY PLAYS A KEY ROLE BEFORE USE: IT SHOULD BE CLEANED AND STORED AS STATED IN THE USER GUIDE.

    Additional Manufacturer Narrative · 0

    THIS IS A CROSS-REPORTING CASE FROM FRANCE.

    Description of Event or Problem · 0

    PATIENT UPDATE: PATIENT HAS NOW FULLY RECOVERED IN THIS EVENT; PATIENT WAS CLEANING THE AFFECTED AREA AND APPLYING CREAM TO AID IN THE HEALING PROCESS. PATIENT HAS PRE-EXISTING ATOPIC SKIN CONDITION, WHICH CAUSED THE HEALING PROCESS TO BE DELAYED. INVESTIGATION CONCLUSION: ROOT CAUSE CANNOT BE CONFIRMED BECAUSE THE BATTERY WAS NOT RETURNED.

    Description of Event or Problem · 0

    IN THIS EVENT, PATIENT EXPERIENCED A BURN-LIKE INJURY BEHIND HIS EAR, WHERE THE HEARING AID IS POSITIONED.. THE DEVICE SHOWS TRACES OF WHITE POWDER AND THE BATTERY CONTACTS ARE CORRODED. THE PATIENT'S DOCTOR CALLED POISON CONTROL CENTER, TO FIND OUT WHAT ACTION THE PATIENT SHOULD TAKE. NO FURTHER INFORMATION ON THE TREATMENT HAS BEEN RECEIVED. THE BATTERY COMPARTMENT ENSURES THAT THE BATTERY DOES NOT GET INTO DIRECT CONTACT WITH THE SKIN.

    Description of Event or Problem · 0

    RESULTS OF TECHNICAL INVESTIGATION: HEARING AID WITHOUT BATTERY WAS RETURNED FOR INVESTIGATION. DEVICE IS POWERED BY ZINC AIR BATTERY; KOH IS THE ELECTROLYTE IN THE BATTERY. TRACE OF WHITE POWDERY MATERIAL OBSERVED IN THE BATTERY COMPARTMENT AND DOOR. BASED ON PREVIOUS INVESTIGATION FINDINGS, SUPPORT THAT BATTERY LEAKAGE OF KOH PRESENTS ITSELF AS A WHITE POWDERY MATERIAL WHICH WAS FOUND ON THE RETURNED HEARING AID. THIS HAS BEEN SEEN PREVIOUSLY IN CASES OF CORROSION, DUE TO THE PRESENCE OF CHLORINE ON THE EXTERNAL SURFACE OF THE BATTERY. CHLORINE IS NOT A COMPONENT USED AS AN INGREDIENT NOR IN THE MANUFACTURING PROCESS FOR HEARING AID BATTERIES. CHLORINE EXPOSURE MAY HAVE OCCURRED AFTER THE BATTERY WAS REMOVED FROM THE CONSUMER PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2520874 WIDEX MOMENT MBB3D 220 OSM INTEGRATED MICRO-ELECTRONICS INC. 21002760 05706069923254

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention