BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALCON STERILE PACK

    MDR report key: 17297441 · Received July 10, 2023

    Report

    Report Number
    MW5119238
    Event Type
    Malfunction
    Date Received
    July 10, 2023
    Date of Event
    June 8, 2023
    Report Date
    July 6, 2023
    Manufacturer
    ALCON RESEARCH, LLC
    Product Code
    LRO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THERE WAS NOT A PATIENT INVOLVED IN THIS EVENT. DURING OPERATING ROOM STERILE SET UP, STERILE PACK FOUND TO HAVE "DEBRIS" THAT APPEARED TO BE A MOUSE/RAT FECES DROPPING. THE FOREIGN MATTER WAS FOUND WITHIN THE MEDLINE GOWN IN THE OUTER FOLD OF THE ALCON PACK. NO PATIENT WAS EXPOSED TO THE ROOM. ONCE THE DEBRIS WAS FOUND, THE ROOM WAS TORN DOWN AND ALL PACKS WITH THE SAME LOT NUMBER WERE PULLED FROM SUPPLY CIRCULATION. REFERENCE REPORT: MW5119239.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1688003 ALCON STERILE PACK GENERAL SURGERY TRAY LRO ALCON RESEARCH, LLC 15AAXK

    Patients

    Seq Age Sex Outcome Treatment
    1 100 YR Prefer Not To Disclose Other