BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDLINE ULTRASOUND PROBE COVER

    MDR report key: 11278838 · Received February 3, 2021

    Report

    Report Number
    MW5099217
    Event Type
    Injury
    Date Received
    February 3, 2021
    Date of Event
    February 2, 2021
    Report Date
    February 2, 2021
    Manufacturer
    SHEATHING TECHNOLOGIES, INC.
    Product Code
    OIP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ULTRASOUND PROBE COVER FOUND TO BE DEFECTIVE BEFORE USE. MEDLINE US. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173256 MEDLINE ULTRASOUND PROBE COVER RADIOLOGY-DIAGNOSTIC KIT OIP SHEATHING TECHNOLOGIES, INC. 0692009H011

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention