BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOM-SINGER

    MDR report key: 6817182 · Received August 24, 2017

    Report

    Report Number
    2025182-2016-00006
    Event Type
    Malfunction
    Date Received
    August 24, 2017
    Date of Event
    October 6, 2016
    Report Date
    October 25, 2016
    Manufacturer
    FREUDENBERG MEDICAL, LLC
    Product Code
    LFB
    UDI-DI
    00848253001784
    PMA / PMN Number
    K131745
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS ORIGINALLY SUBMITTED ON 10/25/2016, IN AN INCORRECT FORMAT. THIS WAS INITIALLY DISCOVERED ON 8/23/2017, AND THIS IS BEING RE-SUBMITTED ON 8/24/2017.

    Description of Event or Problem · 1

    NASAL SEPTAL DEVICE WAS PLACED IN PATIENT SUCCESSFULLY. THE PHYSICIAN DECIDED A DIFFERENT SIZE DEVICE WAS NEEDED AND BEGAN REMOVING THE DEVICE. THE DEVICE WAS REMOVED ONE SIDE AT A TIME. THE LEFT SIDE WAS REMOVED FIRST, SUCCESSFULLY. WHEN THE PHYSICIAN RETURNED TO REMOVE THE RIGHT SIDE, THE DEVICE FELL BACK INTO THE PATIENT'S THROAT AND WAS SUBSEQUENTLY SWALLOWED. THE DEVICE WAS CONFIRMED TO BE IN THE ESOPHAGUS THROUGH X-RAY. THE PHYSICIAN DETERMINED THAT THE DEVICE WILL PASS THROUGH THE PATIENT WITHOUT FURTHER MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597047 BLOM-SINGER NASAL SEPTAL BUTTON LFB FREUDENBERG MEDICAL, LLC 0000025177 00848253001784

    Patients

    Seq Age Sex Outcome Treatment
    1 Other