BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMOSTOP GOLD

    MDR report key: 1616583 · Received February 9, 2010

    Report

    Report Number
    8030904-2010-00001
    Event Type
    Injury
    Date Received
    February 9, 2010
    Date of Event
    November 14, 2009
    Report Date
    February 9, 2010
    Manufacturer
    RADI MEDICAL SYSTEMS AB
    Product Code
    DXC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE EVENT DESCRIPTION ((B) (6)), THERE WAS "NO DIGITAL DISPLAY" AND THAT THE FEMOSTOP WAS REPLACED BY A NEW DEVICE. LINES WERE PULLED SUCCESSFULLY. THE EVENT DESCRIPTION DOES NOT INDICATE THAT THE DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO AN INJURY. HOWEVER, THE REPORT INDICATES THAT AN INJURY HAS OCCURRED. STATED EVENT OUTCOME IS 'DISABILITY OR PERMANENT DAMAGE". WE DON'T KNOW WHAT TYPE OF INJURY OCCURRED AND THERE IS NO INDICATION THAT FEMOSTOP CONTRIBUTED TO THAT INJURY. UNFORTUNATELY THIS ALL THE INFO SENT TO US AND WE DO NOT KNOW WHICH HOSPITAL REPORTED THE EVENT.

    Description of Event or Problem · 1

    EVENT DESCRIPTION (FROM VOLUNTARY REPORT (B) (6)): "APPLIED FEMSTOP TO PULL LINES AND WHEN WENT TO INFLATE TO PULL LINE, NO DIGITAL DISPLAY. WENT AND GOT OLD MODEL. FEMSTOP AND GAUGE AND PULLED LINES SUCCESSFULLY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FEMOSTOP GOLD CLAMP, VASCULAR DXC RADI MEDICAL SYSTEMS AB 11165 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Disability