BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACS

    MDR report key: 20450807 · Received October 15, 2024

    Report

    Report Number
    20450807
    Event Type
    Malfunction
    Date Received
    October 15, 2024
    Date of Event
    June 26, 2024
    Report Date
    July 25, 2024
    Manufacturer
    AMERICAN CONTRACT SYSTEMS
    Product Code
    LRO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    THE STAFF WERE OPENING THE STERILE SUPPLIES FOR A HEMORRHOIDECTOMY. THE SCRUB AND NURSE NOTICED THAT THERE WAS A HAIR IN THE MINOR PACK. THE HAIR WAS LOCATED IN THE KIDNEY BASIN WITH THE STICKERS. THE STAFF IMMEDIATELY DISCARDED THE SUPPLIES AND HAD TO REOPEN MORE SUPPLIES FOR THE CASE. THIS WAS DONE BEFORE THE PATIENT ENTERED THE OPERATING ROOM. THE REFERENCE NUMBER FOR THE MINOR PACK THAT CONTAINED THE HAIR IS 176549 AND THE LOT NUMBER IS 880241.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323876 ACS GENERAL SURGERY TRAY LRO AMERICAN CONTRACT SYSTEMS HOMN44F 880241

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Unknown