BEUDAMED
    FDA Adverse Event Other Summary report: N

    1030451-2012-00003

    MDR report key: 3118742 · Received June 7, 2012

    Report

    Report Number
    1030451-2012-00003
    Event Type
    Other
    Date Received
    June 7, 2012
    Product Code
    LRS
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    ON 05/31/2012, MEDICAL ACTION INDUSTRIES (MAI) (B)(4) FACILITY RECEIVED FROM THE FDA, A COPY MEDWATCH REPORT WHICH WAS THEN FORWARDED TO MAI COMPLAINT UNIT (B)(4). MAI HAD PREVIOUSLY RECEIVED THIS COMPLAINT ON 05/23/2012 AND HAD ASSIGNED COMPLAINT # (B)(4). (B)(6) WAS CONTACTED IMMEDIATELY FOR FURTHER INFO AND RGA #(B)(4) AND (B)(4) LABEL TRACKING WERE ISSUED TO (B)(6) TO RETURN THE COMPLAINED CHLORAPREP TO OUR (B)(4) FACILITY. MAI CONTACTED CAREFUSION THE MFR OF THE COMPLAINED CHLORAPREP AND ISSUED SCAR # (B)(4), CAREFUSION ISSUED COMPLAINT # (B)(4). THE COMPLAINED CHLORAPREP SAMPLE WAS RECEIVED AT OUR (B)(4) FACILITY ON 06/06/2012 AND IMMEDIATELY SHIPPED OVERNIGHT TO: CAREFUSION, ATTN. (B)(4) - FRONT DESK. CAREFUSION'S RESPONSE TO SCAR # (B)(4) WILL BE REVIEWED AND KEPT ON FILE ONCE RECEIVED. IN ADDITION, THIS OCCURRENCE HAS BEEN ENTERED INTO MAI'S FORMAL COMPLAINT SYSTEM IN WHICH DEFECT TRENDS ARE CLOSELY MONITORED.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LRS

    Patients

    Seq Age Sex Outcome Treatment
    1