BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLOM-SINGER

    MDR report key: 6826017 · Received August 28, 2017

    Report

    Report Number
    2025182-2017-00005
    Event Type
    Injury
    Date Received
    August 28, 2017
    Date of Event
    August 1, 2017
    Report Date
    August 28, 2017
    Manufacturer
    FREUDENBERG MEDICAL, LLC
    Product Code
    EWL
    UDI-DI
    00081330701014
    PMA / PMN Number
    K930105
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE REGISTERED NURSE/CARE COORDINATOR REPORTED THAT ONE OF THE PATIENTS AT THEIR HOSPITAL COUGHED WHILE INSERTING A PROSTHESIS AND ASPIRATED THE DEVICE. THE PROSTHESIS HAS BEEN REMOVED FROM THE PATIENT. THE NURSE INDICATED THAT THE DEVICE WOULD NOT BE RETURNED FOR EVALUATION. ADDITIONAL ATTEMPTS WERE MADE TO CONTACT THE NURSE AND PATIENT; HOWEVER, (B)(4) WAS UNABLE TO REACH THE NURSE OR PATIENT FOR FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603296 BLOM-SINGER VOICE PROSTHESIS EWL FREUDENBERG MEDICAL, LLC 00081330701014

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention