BEUDAMED
    FDA Adverse Event Death Summary report: N

    STERICARE 0.9% SODIUM CHLORIDE IRRIGATION USP, 250ML

    MDR report key: 18358050 · Received December 18, 2023

    Report

    Report Number
    MW5149357
    Event Type
    Death
    Date Received
    December 18, 2023
    Date of Event
    October 21, 2023
    Report Date
    December 15, 2023
    Manufacturer
    NURSE ASSIST, LLC
    Product Code
    NGT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    USED THE RECALLED PRODUCT TO CLEAN AN OPEN WOUND ON RIGHT FOOT, AND DEVELOPED AN INFECTION WHICH REQUIRED AN ANTIBIOTIC TO RESOLVE ON (B)(6) 2023. OPEN WOUND TO RIGHT FOOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2110890 STERICARE 0.9% SODIUM CHLORIDE IRRIGATION USP, 250ML SALINE, VASCULAR ACCESS FLUSH NGT NURSE ASSIST, LLC 6270 23076070

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Death| R 81MG ASPIRIN | CALCIUM| JANUVISA| LANTUS INSULIN | METFORMIN | MULTIVITAMIN | NOVALOG INSULIN | TRULICITY | VITAMIN E, VITAMIN D