BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY

    MDR report key: 7332827 · Received March 12, 2018

    Report

    Report Number
    8020889-2018-00032
    Event Type
    Injury
    Date Received
    March 12, 2018
    Date of Event
    February 20, 2018
    Report Date
    March 13, 2018
    Manufacturer
    MALLINCKRODT MEDICAL
    Product Code
    BSY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS PRODUCT IS NOT SOLD IN THE U.S. AND IS NOT ASSOCIATED TO ANY SIMILAR DESIGN. REGULATORY REPORT 8020889-2018-00032 IS NO LONGER APPLICABLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS NOT SOLD IN US AND IS 510(K) EXEMPT.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING USE, THE DEVICE'S BALLOON HAD WATER AND SECRETIONS INSIDE. ALSO, IT WAS REPORTED THAT THE SUCTIONING PORT WAS DETACHED FROM THE TUBE AFTER THE INSERTION. THE CUSTOMER REPORTED THAT THE PATIENT WAS RE-INTUBATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175513 SHILEY BSY MALLINCKRODT MEDICAL 313880 201710217X

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention