BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BILLINGS CLINIC SC T&A PACK

    MDR report key: 10294792 · Received July 20, 2020

    Report

    Report Number
    10294792
    Event Type
    Malfunction
    Date Received
    July 20, 2020
    Date of Event
    July 15, 2020
    Report Date
    July 15, 2020
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    OGR
    UDI-DI
    10889942576081
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    SC T&A PACK MADE BY MEDLINE IS SUPPOSED TO CONTAIN 10-4X4 GAUZE PADS. THE PACK CAME SEALED WITH ONLY 6-4X4 GAUZE PADS. THE PACK WAS OPENED IN THE OR FOR THE UPCOMING CASE. A COUNT OF 6-4X4 GAUZE PADS WERE FOUND INSTEAD OF THE EXPECTED 10. THE ROOM AND PATIENT WERE DOUBLE CHECKED JUST IN CASE THEY FELL WHILE OPENING THE PACK. THE COUNT OF 6 WAS CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759981 BILLINGS CLINIC SC T&A PACK EAR, NOSE, AND THROAT SURGICAL TRAY OGR MEDLINE INDUSTRIES, INC. DYNJ33657B 20AMC323 10889942576081

    Patients

    Seq Age Sex Outcome Treatment
    1