BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOUNDBITE HEARING SYSTEM

    MDR report key: 3285711 · Received August 9, 2013

    Report

    Report Number
    3009200826-2013-00001
    Event Type
    Injury
    Date Received
    August 9, 2013
    Date of Event
    January 1, 2013
    Report Date
    July 15, 2013
    Manufacturer
    SONITUS MEDICAL
    Product Code
    LXB
    PMA / PMN Number
    K110831
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACT ROOT CAUSE OF THE FUNGAL INFECTION IS UNKNOWN. THERE WAS NO DEVICE MALFUNCTION REPORTED. THE PATIENT SAID THAT SHE DID NOT CLEAN THE DEVICE REGULARLY AFTER EACH MEAL. THE LACK OF PROPER CLEANING OF THE DEVICE MAY HAVE CONTRIBUTED TO THE EVENT. THE SOUNDBITE PATIENT AND PHYSICIAN IFUS BOTH GIVE INSTRUCTIONS TO RINSE THE DEVICE AFTER EACH MEAL AND TO CLEAN FOOT PARTICLES FROM THE DEVICE WITH A SOFT TOOTHBRUSH. IT WAS REPORTED TO THE MANUFACTURER THAT THE PATIENT EXPERIENCED FUNGAL INFECTIONS WHILE WEARING THE ITM PRIOR TO THE EVENT; THE FUNGAL INFECTIONS WERE TREATED BY A DENTIST AND BELIEVED TO BE RESOLVED.

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(4) 2013 THAT THE PATIENT SAW AN ORAL SPECIALIST AND WAS DIAGNOSED, THROUGH INITIAL CLINICAL IMPRESSION, WITH REMNANTS OF A FUNGAL INFECTION WHERE THE ITM DEVICE IS WORN. THE PATIENT REPORTED THAT SHE DID NOT CLEAN THE ITM ACCORDING TO THE INSTRUCTIONS FOR USE. THE PATIENT WAS PRESCRIBED WITH CLOTRIMAZOLE TO ADDRESS THE INFECTION AND NYSTATIN TO SOAK THE ITM. THERE WAS NO DEVICE MALFUNCTION ASSOCIATED WITH THE EVENT AND NO FURTHER SEQUELAE WERE REPORTED. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381129 SOUNDBITE HEARING SYSTEM PROSTHETIC DEVICE, BONE CONDUCTION LXB SONITUS MEDICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention