BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEROYAL ESMARK BANDAGES

    MDR report key: 9844833 · Received March 17, 2020

    Report

    Report Number
    3014527682-2020-00004
    Event Type
    Malfunction
    Date Received
    March 17, 2020
    Date of Event
    February 3, 2020
    Report Date
    March 17, 2020
    Manufacturer
    DEROYAL INDUSTRIES
    Product Code
    FQM
    UDI-DI
    50749756024537
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    WHITE FLAKING PARTICLES COMING OFF ESMARK PACKAGING WHICH IS PLACED INSIDE BOWL WITHIN CUSTOM PROCEDURE KIT 880119-HAND PACK, LOT #1925636745, UDI#(B)(4). THE USER REPORTED THAT THIS OCCURED ON 3 DIFFERENT DATES: (B)(6) 2020. THE USER REPORTED THAT THE BOWL WAS WIPED OUT BY THE SCRUB NURSE BEFORE POURING IRRIGATION INTO BOWL. THERE WAS NO REPORTED HARM TO THE PATIENT NOR WAS THERE A DELAY TO THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309257 DEROYAL ESMARK BANDAGES ESMARK, BANDAGE 4X9FT FQM DEROYAL INDUSTRIES 50118138 50749756024537

    Patients

    Seq Age Sex Outcome Treatment
    1