BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAND PK, MID 050040, GAUZE 4X4 XRAY RFD

    MDR report key: 16033261 · Received December 22, 2022

    Report

    Report Number
    16033261
    Event Type
    Malfunction
    Date Received
    December 22, 2022
    Date of Event
    October 26, 2022
    Report Date
    December 16, 2022
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    OJH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SURGEON NOTICED SMALL FLECKS OF BLUE FALLING INTO SURGICAL SITE FROM THE GAUZE 4X4 XRAY RFD THAT WAS INCLUDED IN HAND PK, MID 050040.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2858318 HAND PK, MID 050040, GAUZE 4X4 XRAY RFD ORTHOPEDIC TRAY OJH MEDLINE INDUSTRIES, INC. DYNJ80249 22FBT319

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown