BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLOM-SINGER ADVANTAGE INDWELLING VOICE PROSTHESIS

    MDR report key: 5227133 · Received November 16, 2015

    Report

    Report Number
    2025182-2015-00005
    Event Type
    Injury
    Date Received
    November 16, 2015
    Date of Event
    August 8, 2015
    Report Date
    November 16, 2015
    Manufacturer
    FREUDENBERG MEDICAL, LLC DBA HELIX MEDICAL, LLC
    Product Code
    EWL
    PMA / PMN Number
    K991587
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(4) 2015: THE PATIENT SENT AN EMAIL TO FREUDENBERG MEDICAL STATING THEY HAD 2 EMERGENCY ROOM VISITS TO FIND WHERE THEIR INDWELLING VOICE PROSTHESIS HAD GONE. THEY INITIALLY WENT TO THE EMERGENCY ROOM AND THEY TOOK X-RAYS AND THEY COULD NOT SEE IT. "THEY ASSUMED IT WENT DOWN THE ESOPHAGUS EVEN THOUGH" THE PATIENT STATED THEY WERE "BREATHING HEAVILY." THE PATIENT RETURNED TO THE EMERGENCY ROOM. THE DOCTOR LISTENED TO THEIR LUNGS AND "COULD TELL SOMETHING WAS WRONG BY THE RIGHT LUNG." A CAT SCAN WAS DONE WHICH SHOWED "WHERE IT WAS LOCATED." THE PULMONOLOGIST TOOK THE PATIENT TO THE OPERATING ROOM, GAVE THE PATIENT ANESTHESIA AND REMOVED IT. THE REMOVED DEVICE WAS GIVEN TO THE PATIENT WHO NOTED THAT ONE OF THE FLANGES WAS MISSING. ON (B)(4) 2015: AN SLP FROM FREUDENBERG MEDICAL SPOKE TO THE PATIENT AND THE FOLLOWING INFORMATION WAS PROVIDED: PATIENT "IS IN GOOD HEALTH - NO ADVERSE HEALTH ISSUES AS A RESULT OF THE INCIDENT." PRODUCT WAS PLACED IN (B)(6) 2014. TIMELINE/EVENTS PER PATIENT REPORT: APPROXIMATELY 1 WEEK BEFORE THE PROSTHESIS REPORTEDLY DISLODGED, THEY "EXPERIENCED SOME GASTRIC ISSUES" WHICH THEY "NOW RETROSPECTIVELY THINK WAS RELATED TO THE ESOPHAGEAL FLANGE FALLING OFF AND PASSING THROUGH" THEIR DIGESTIVE SYSTEM. DURING THAT SAME WEEK, THE PATIENT NOTICED THAT THE VOICE PROSTHESIS APPEARED TO BE PISTONING. THE "VALVE DISLODGED" AND THE PATIENT PLACED A PATIENT CHANGEABLE VOICE PROSTHESIS. THE PATIENT HAD A CHEST X-RAY WHICH WAS NEGATIVE. THE PATIENT FELT SHORT OF BREATH AND CALLED SLPS WHO TOLD THEM TO GO FOR FURTHER EVALUATION AS IT WAS POSSIBLE THAT THE ASPIRATED PROSTHESIS DID NOT SHOW UP ON THE X-RAY. THE PATIENT HAD A CT OF THE LUNG WHICH SHOWED THE PRESENCE OF THE PROSTHESIS IN THEIR AIRWAY. THE PATIENT UNDERWENT A BRONCHOSCOPY AND A PULMONOLOGIST REMOVED THE PROSTHESIS. SUBSEQUENTLY, THE PATIENT WAS IN GOOD HEALTH. ON 9/4/2015: DEVICE WAS RECEIVED AT FREUDENBERG MEDICAL WITH A NOTE FROM THE PATIENT WHICH STATED: "ENCLOSED IS DEFECTIVE ADVANTAGE INDWELLING. REMOVED WITH BRONCHOSCOPE BY PULMONOLOGIST ... ON (B)(6) 2015."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756830 BLOM-SINGER ADVANTAGE INDWELLING VOICE PROSTHESIS VOICE PROSTHESIS EWL FREUDENBERG MEDICAL, LLC DBA HELIX MEDICAL, LLC AD2012-NS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R