BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS

    MDR report key: 24604342 · Received March 16, 2026

    Report

    Report Number
    2025182-2026-00001
    Event Type
    Injury
    Date Received
    March 16, 2026
    Date of Event
    November 3, 2025
    Report Date
    March 11, 2026
    Manufacturer
    FREUDENBERG MEDICAL, LLC
    Product Code
    EWL
    UDI-DI
    00813307010951
    PMA / PMN Number
    K082206
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON VISUAL INSPECTION OF THE VOICE PROSTHESIS IT WAS CLEAR THAT THE FLAP ON THE ESOPHAGEAL SIDE OF THE DEVICE WAS MISSING. THERE ARE NO OBVIOUS TEARS RIPS OR ABRASIONS VISIBLE UNDER THE MICROSCOPE, IN THE BARREL OF THE VOICE PROSTHESIS OR AROUND WHERE THE ESOPHAGEAL VALVE FLAP WOULD HAVE BEEN LOCATED. THE VALVE FLAP THAT WAS ASPIRATED AND FOUND IN THE KARINA VIA TRACHEOSCOPY, WAS NOT PROVIDED FOR INSPECTION.

    Description of Event or Problem · 0

    THE SPEAKING VALVE WAS INSERTED 5 DAYS PRIOR TO THE INCIDENT. THE PATIENT ATTENDED ED WITH UNCONTROLLED ASPIRATION OF SECRETIONS AND FOOD/FLUIDS FROM VALVE. ON CLOSER INSPECTION OF THE VALVE, THERE APPEARED TO BE NO ANTERIOR FLAP. TRACHEOSCOPY IDENTIFIED A SMALL PLASTIC FLAP IN THE CARINA BUT WAS NOT SEEN ON XRAY. THE PATIENT REPORTED THAT HE HAD BEEN CLEANING HIS VALVE IN THE NORMAL WAY, WITH NO FORCE AND WITH THE CORRECT EQUIPMENT. SLT THAT PLACED THE VALVE SAID THAT SHE HAD NOT NOTICED ANY PROBLEMS WITH THE VALVE AT THE TIME OF INSERTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697 BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS EWL FREUDENBERG MEDICAL, LLC DV 2010-NS 0000321626 00813307010951

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other