BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFLATOMATIC 3000 REG-HI

    MDR report key: 11681 · Received February 14, 1994

    Report

    Report Number
    11681
    Event Type
    Injury
    Date Received
    February 14, 1994
    Date of Event
    December 8, 1993
    Report Date
    January 20, 1994
    Manufacturer
    ZIMMER PATIENT CARE DIVISION
    Product Code
    KCY
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ADM THRU ED 12/8/93 WITH DISPLACED ANKLE FRACTURE (L MEDIAL MALLELOUS AND L FIBULA). FOOT NOTED TO BE WELL PERFUSED BUT PULSES NOT PALPABLE DUE TO EDEMA. TO OR WHERE PNEUMATIC TOURNIQUET APPLIED AND INFLATED TO 300MM. ORIF PERFORMED. TOURNIQUET THEN RELEASED & NO RETURN TO VASCULARITY NOTED. EMERGENT L FEMORAL EMBOLECTOMY PERFORMED; THREE PIECES OF CLOT REMOVED. AFTER CLOSURE, DOPPLER PULSES INDICATED SATISFACTORY FLOW AT DORSUM, AND CAPILLARY REFILL INSTANTANEOUS. DC'D 12/13/93. ON DC FOOT WARM, PULSES STRONG. PT NOTED DECREASED SENSATION ALONG DORSUM OF L FOOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFLATOMATIC 3000 REG-HI TOURNIQUET REGULATOR (PNEUMATIC CUFF INFLATOR) KCY ZIMMER PATIENT CARE DIVISION N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| R