BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTE UTERAL ACCESS SHEATH

    MDR report key: 4894333 · Received July 6, 2015

    Report

    Report Number
    4894333
    Event Type
    Malfunction
    Date Received
    July 6, 2015
    Date of Event
    June 30, 2015
    Report Date
    July 6, 2015
    Manufacturer
    APPLIED MEDICAL RESOURCES CORP
    Product Code
    FED
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US

    Narratives

    Description of Event or Problem · 1

    THE DOCTOR WAS INSERTING ACCESS SHEATH AND IT BECAME LOOSE. NO HARM TO PATIENT. ANOTHER DEVICE OBTAINED AND PROCEDURE CONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435152 FORTE UTERAL ACCESS SHEATH ENDOSCOPIC ACCESS OVERTUBE, GASTROENTEROLOGY-UROLOGY FED APPLIED MEDICAL RESOURCES CORP * 1191293

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR