BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRYKER COAXIAL FEMORAL CANAL TIP

    MDR report key: 10903034 · Received November 24, 2020

    Report

    Report Number
    MW5098065
    Event Type
    Injury
    Date Received
    November 24, 2020
    Date of Event
    November 13, 2020
    Report Date
    November 20, 2020
    Manufacturer
    STRYKER CORP
    Product Code
    FQH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2020 THIS (B)(6) YEAR-OLD MALE PRESENTED TO THE ED WITH RIGHT SHOULDER PAIN AFTER HAVING RECENTLY BEEN BIT BY A SPIDER. SITE CULTURES WERE POSITIVE FOR INFECTION AND HE WAS ADMITTED TO THE HOSPITAL FOR SURGERY. ON (B)(6) 2020 THE PATIENT UNDERWENT AN INCISION AND DRAINAGE WITH WASHOUT OF THE RIGHT SHOULDER AND RIGHT TRICEPS. THE WOUNDS WERE LEFT OPEN FOR ANOTHER I&D AT A LATER TIME. ON (B)(6) 2020 THE PATIENT UNDERWENT A SECOND, I&D AND WHEN THE SURGEON WAS ASSESSING THE WOUND, HE NOTED A SMALL PIECE OF PLASTIC IN THE WOUND. IT WAS REMOVED AND IDENTIFIED TO BE THE TIP OF THE IRRIGATION DEVICE. THIS PIECE HAD BROKEN OFF DURING THE FIRST I&D AND WAS NOT NOTED AT THAT TIME. THERE WAS NO APPARENT INJURY TO THE PATIENT. DEVICE WAS THE STRYKER COAXIAL FEMORAL CANAL TIP 0210-007-000. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1354709 STRYKER COAXIAL FEMORAL CANAL TIP LAVAGE, JET FQH STRYKER CORP

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other