BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLOM-SINGER CLASSIC VOICE PROSTHESIS

    MDR report key: 3918089 · Received June 4, 2014

    Report

    Report Number
    2025182-2014-00001
    Event Type
    Injury
    Date Received
    June 4, 2014
    Date of Event
    January 1, 2013
    Report Date
    May 5, 2014
    Manufacturer
    HELIX MEDICAL, LLC
    Product Code
    EWL
    PMA / PMN Number
    K932120
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SEE ATTACHED COPY OF JOURNAL ARTICLE: QUINN K, ET AL. BMJ CASE REPORT 2013. DOI:10.1136/BCR-2013-008572): "AN UNUSUAL CAUSE OF PNEUMONIA: SEEN BUT NOT HEARD".

    Description of Event or Problem · 1

    DURING A LITERATURE REVIEW THE FOLLOWING CASE REPORT WAS FOUND PUBLISHED IN THE EBRITISH JOURNAL OF MEDICINE (QUINN K, ET AL. BMJ CASE REPORT 2013. DOI:10.1136/BCR-2013-008572): "AN UNUSUAL CAUSE OF PNEUMONIA: SEEN BUT NOT HEARD". IT REPORTED THAT "A (B)(6) YEAR OLD MAN WITH HISTORY OF LARYNGECTOMY SECONDARY TO SQUAMOUS CELL CARCINOMA OF THE LARYNX AND LEFT LOWER LOBECTOMY FOR NON-SMALL CELL CARCINOMA OF THE LUNG, PRESENTED ACUTELY WITH WEIGHT LOSS, GENERAL MALAISE, DYSPNEA AND A PRODUCTIVE COUGH FOR 2 MONTHS." HE WAS TREATED WITH IV ANTIBIOTICS "FOR PROBABLE INFECTION WITH MINIMAL IMPROVEMENT IN SYMPTOMS." "DUE TO HIS MEDICAL HISTORY AND WEIGHT LOSS, A CT CHEST SCAN WAS PERFORMED IN THE RIGHT LOWER LOBE BRONCHUS THERE APPEARED TO BE SOFT TISSUE CHANGE WHICH WAS PRESUMED TO BE RELATED TO RETAINED SECRETIONS. A BRONCHOSCOPY WAS SUBSEQUENTLY PERFORMED TO EXCLUDE AN ENDOBRONCHIAL LESION. THIS REVEALED EXTENSIVE MUCOUS PLUGGING OF THE RIGHT MAIN BRONCHUS AND OPACITY IN THE DISTAL RIGHT MAIN BRONCHUS. "THE BRONCHOSCOPY IMAGE SHOWED AN ASPIRATED BLOM-SINGER VOICE PROSTHESIS WHICH WAS REMOVED USING A RIGID BRONCHOSCOPY. AFTER REMOVAL OF THE VOICE PROSTHESIS, THE PATIENT MADE A FULL RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325644 BLOM-SINGER CLASSIC VOICE PROSTHESIS VOICE PROSTHESIS EWL HELIX MEDICAL, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR