BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RBI2

    MDR report key: 5839102 · Received August 2, 2016

    Report

    Report Number
    3005921952-2016-00001
    Event Type
    Injury
    Date Received
    August 2, 2016
    Date of Event
    November 1, 2014
    Report Date
    August 2, 2016
    Product Code
    FCK
    PMA / PMN Number
    K062159
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A RETROSPECTIVE REPORT FROM 2015. INCIDENT HAPPENED IN THE (B)(6) AND WAS REPORTED BY HOSPITAL 6 MONTHS AFTER INCIDENT DATE.

    Description of Event or Problem · 1

    POST BIOPSY BLEEDING .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493351 RBI2 RBI2 SUCTION RECTAL BIOPSY SYSTEM, FCK

    Patients

    Seq Age Sex Outcome Treatment
    1 9 MO Required Intervention