BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHONAK

    MDR report key: 16868890 · Received May 4, 2023

    Report

    Report Number
    3005085999-2023-00004
    Event Type
    Injury
    Date Received
    May 4, 2023
    Date of Event
    March 24, 2023
    Report Date
    April 5, 2023
    Manufacturer
    SONOVA AG
    Product Code
    OSM
    UDI-DI
    07613275553169
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS MANUFACTURED IN DECEMBER 2021. NO DEVIATIONS IN PRODUCTION PROCESS HAVE BEEN IDENTIFIED. THE DEVICE SUCCESSFULLY PASSED ALL THE QUALITY TESTS. ISSUED TO CUSTOMER/USER (B)(6) 2021. NO FURTHER SERVICE HAS BEEN PERFORMED ON THE REPORTED DEVICE BEFORE THE INCIDENT. DEVICE HAS BEEN REQUESTED FOR ANALYSIS.BUT PATIENT HAS DECLINED TO RETURN THE DEVICE.

    Additional Manufacturer Narrative · 0

    AUGUST 3, 2023 NO FURTHER INFORMATION ON THE INCIDENT COULD BE OBTAINED. THIS IS THE FINAL REPORT. THE MANUFACTURER WILL REOPEN THE CASE IF FURTHER INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2023 PATIENT WAS FOUND IN A ROOM WITH THEIR LEFT EAR BLEEDING AND THE HEARING AID MELTED AND BLACKENED. THE DEVICE INVOLVED IS PHONAK VIRTO B90-13. PATIENT WAS TAKEN TO THE ER WHERE THEY RECEIVED 3 STITCHES IN THEIR CONCHA. ON (B)(6) 2023 PATIENT WAS SEEN BY THE HCP AND THE ENT CLINIC. ENT REMOVED THE STITCHES AND THE PATIENT'S EAR LOOKED WELL HEALED.THE PATIENT REFUSED TO RETURN THE DEVICE FOR ANALYSIS. INVESTIGATION IS ONGOING. THIS IS THE INITIAL REPORT, SUPPLEMENTAL REPORT WILL BE ISSUED WHEN MORE INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620366 PHONAK VIRTO B90-13 OSM SONOVA AG 063023601 07613275553169

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other