BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERICARE SOLUTIONS USP STERILE WATER, 1000 ML BOTTLE

    MDR report key: 21157676 · Received January 15, 2025

    Report

    Report Number
    21157676
    Event Type
    Malfunction
    Date Received
    January 15, 2025
    Date of Event
    January 10, 2025
    Report Date
    January 10, 2025
    Manufacturer
    NURSE ASSIST, LLC
    Product Code
    FRO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    BOTTLE OF STERILE WATER WAS PICKED FOR CASE. WHEN OPENED, 1/2 OF THE SEAL WAS SEEN TO BE MISSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    969040 STERICARE SOLUTIONS USP STERILE WATER, 1000 ML BOTTLE DRESSING, WOUND, DRUG FRO NURSE ASSIST, LLC 6291 24098454

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female