BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATS 3000 TOURNIQUET

    MDR report key: 2080677 · Received April 26, 2011

    Report

    Report Number
    1526350-2011-00075
    Event Type
    Injury
    Date Received
    April 26, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 29, 2011
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    KCY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER; HOWEVER, THE INVESTIGATION WAS NOT COMPLETED AT THE TIME OF THIS REPORT. A FOLLOW UP MEDWATCH WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZIMMER ATS 3000 UNIT WAS USED ON A SURGICAL CASE WHEREIN THE PATIENT LOST APPROXIMATELY 600ML OF BLOOD. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATS 3000 TOURNIQUET ATS 3000 TOURNIQUET KCY ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1