BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDINAL HEALTH

    MDR report key: 12461269 · Received September 8, 2021

    Report

    Report Number
    12461269
    Event Type
    Injury
    Date Received
    September 8, 2021
    Date of Event
    August 10, 2021
    Report Date
    September 2, 2021
    Manufacturer
    CARDINAL HEALTH
    Product Code
    GDY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT INVOLVED IN A MVA ON (B)(6) 2021 AND TAKEN TO THE OPERATING ROOM ON (B)(6). ON (B)(6) A SPONGE WAS FOUND IN THE PT'S PELVIS DURING A PELVIC ORIF. THE SPONGE PIECE (BLUE CLOTH LOOP) WAS THE PIECE THAT WAS REMOVED. ON (B)(6) WHEN THE PATIENT RETURNED TO THE OPERATING ROOM FOR REMOVAL OF PACKING ALL COUNTS WERE CORRECT. IT WAS DETERMINED THAT ON (B)(6) WHEN THE ORTHOPEDIC SURGEON APPLIED A PLATE AND SCREW INTO THE PT'S PELVIS HE HAD APPLIED THE SCREW THREW THE BLUE CLOTH LOOP PORTION OF THE SPONGE CAUSING THE BLUE CLOTH LOOP TO WRAP AROUND THE SCREW. THIS WAS ONLY NOTICEABLE WHEN THE PLATE AND SCREW WAS REMOVED ON (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1340937 CARDINAL HEALTH LAP SPONGE 18X18 GDY CARDINAL HEALTH

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R