BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTE AXP URETERAL ACCESS SHEATH

    MDR report key: 1048171 · Received May 19, 2008

    Report

    Report Number
    MW5006946
    Event Type
    Malfunction
    Date Received
    May 19, 2008
    Date of Event
    February 28, 2008
    Report Date
    May 19, 2008
    Manufacturer
    APPLIED MEDICAL
    Product Code
    FED
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A URETERAL ACCESS SHEATH UNRAVELED IN THE GU SYSTEM OF A PATIENT. NO HARM WAS DONE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FORTE AXP URETERAL ACCESS SHEATH URETERAL ACCESS SHEATH FED APPLIED MEDICAL B7016 1035742

    Patients

    Seq Age Sex Outcome Treatment
    1