BEUDAMED
    FDA Adverse Event Other Summary report: N

    SAMPLE ITEM COMPONENT

    MDR report key: 2872376 · Received December 7, 2012

    Report

    Report Number
    1423395-2012-00003
    Event Type
    Other
    Date Received
    December 7, 2012
    Date of Event
    November 7, 2012
    Report Date
    December 3, 2012
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    LRO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY RECEIVED TWO COMPONENT SAMPLES AND UTILIZED THEM DURING TWO CATARACT SURGERIES. THE ITEMS WERE NOT LABELED AS STERILE. THE CLINICIAN DID NOT REALIZE THEY WERE NOT STERILE AND USED THEM. THE INCIDENT WAS IDENTIFIED AFTER THE PROCEDURES HAS BEEN COMPLETED. THE SAMPLES WERE NOT RETAINED. THERE WERE NO COMPLICATIONS NOTED DURING EITHER PROCEDURE. THERE WAS NO CHANGE TO THE POST OP CARE AND NO MEDICAL/SURGICAL INTERVENTION WAS INITIATED AS A RESULT. THE PATIENTS WERE FOLLOWED POSTOPERATIVELY AND NO COMPLICATIONS DEVELOPED.

    Description of Event or Problem · 1

    TWO NON-STERILE SAMPLE COMPONENTS WERE USED DURING A SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAMPLE ITEM COMPONENT LRO MEDLINE INDUSTRIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other