BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 1111650 · Received June 4, 2008

    Report

    Report Number
    2026095-2008-00062
    Event Type
    Other
    Date Received
    June 4, 2008
    Manufacturer
    I-FLOW CORP.
    Product Code
    FRN
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THIS INCIDENT WAS REC'D FOR EVAL AND INVESTIGATION. THE INFO CONTAINED HEREIN IS BASED ON THE INFO PROVIDED BY THE INITIAL REPORTER AND THE EVAL OF THE SAMPLE. THE SAMPLE REC'D WAS NOT THE ACTUAL DEVICE, BUT WAS FROM THE SAME LOT AND STORAGE AREA AS THE DEVICE THAT WAS REPORTED TO HAVE FAILED. THE EVAL OF THE SHEATH RETURNED FOUND IT TO BREAK WHEN EVALUATED. FURTHER EVALUATION IS BEING CONDUCTED. RETAIN PROD FROM THE SAME LOT NUMBER AS THE SHEATH WAS EVALUATED. NO PROBLEMS WERE IDENTIFIED. NO BREAKAGE OCCURRED AND THE PROD MET SPEC. THIS REPORT IS STILL UNDER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * * FRN I-FLOW CORP. * *

    Patients

    Seq Age Sex Outcome Treatment
    1