BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDLINE

    MDR report key: 9192180 · Received October 11, 2019

    Report

    Report Number
    MW5090362
    Event Type
    Injury
    Date Received
    October 11, 2019
    Date of Event
    October 1, 2019
    Report Date
    October 9, 2019
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AR, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT PRESENTED FOR RIGHT HIP INJECTION FOR OA. A TPI INJECTION WAS ADMINISTERED TO THE RIGHT GLUTEAL MUSCLE. WHILE GIVING INJECTION THE 25 GAUGE NEEDLE BROKE INTO THE RIGHT GLUTEAL MUSCLE. PT WAS SENT TO THE ER TO HAVE NEEDLE REMOVED. THERE IS A THIN METALLIC LINEAR FOREIGN BODY POSTERIORLY OVERLYING THE SACRUM AT THE LEVEL OF THE FEMORAL HEAD/NECK. THIS FOREIGN BODY LIKELY CORRELATES WITH A LINEAR METALLIC DENSITY JUST LATERAL TO THE RIGHT FEMORAL NECK ON AP PROJECTION. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    977041 MEDLINE HYPODERMIC NEEDLE, SINGLE LUMEN FMI MEDLINE INDUSTRIES, INC. 181215

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention