BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHILEY

    MDR report key: 8905700 · Received August 19, 2019

    Report

    Report Number
    2936999-2019-00555
    Event Type
    Malfunction
    Date Received
    August 19, 2019
    Date of Event
    June 1, 2019
    Report Date
    October 29, 2019
    Manufacturer
    MMJ SA DE CV(USD)
    Product Code
    BTR
    UDI-DI
    20884521620251
    PMA / PMN Number
    K151381
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT HAS BEEN REASSESSED AND FOUND TO BE A NON-MDR REPORTABLE COMPLAINT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE UNIT HAD A STICKY RESIDUE END OF THE TUBE. CLOUDY, ROUGH SURFACE THROUGHOUT. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701040 SHILEY TUBE, TRACHEAL (W/WO CONNECTOR) BTR MMJ SA DE CV(USD) 86234 18L0196JZX 20884521620251

    Patients

    Seq Age Sex Outcome Treatment
    1