BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REFLEX AEC 35

    MDR report key: 117861 · Received August 30, 1997

    Report

    Report Number
    1824347-1997-00003
    Event Type
    Injury
    Date Received
    August 30, 1997
    Date of Event
    July 2, 1997
    Report Date
    August 15, 1997
    Manufacturer
    RICHARD-ALLAN MEDICAL IND., INC.
    Product Code
    GAG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT HAD TO BE RETURNED TO SURGERY FOR RENEWED BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REFLEX AEC 35 ENDOSCOPIC STAPLING DEVICE GAG RICHARD-ALLAN MEDICAL IND., INC. 4325 14FEB02

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention