BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCD DEVICE - SEQUEL SYSTEM

    MDR report key: 230005 · Received June 30, 1999

    Report

    Report Number
    230005
    Event Type
    Injury
    Date Received
    June 30, 1999
    Date of Event
    June 8, 1999
    Report Date
    June 23, 1999
    Manufacturer
    KENDALL VASCULAR THERAPY
    Product Code
    JOW
    Report Source
    User Facility report
    Reporter Location
    ME, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THIGH SCD STOCKING/SLEEVE APPLIED IN OR AND USED W/ SCD SEQUEL SYSTEM. PT HAD THE SCD SYSTEM ON FOR ABOUT 2 HOURS WHEN DISCOLORATION OF TOES WAS NOTICED. SCD PRODUCT WAS REMOVED AND WARM COMPRESSES APPLIED. COLOR IMPROVED. CYANOSIS TO BOTH FEET DESCRIBED AS SEVERE BY ATTENDING PHYSICIAN. PT. WAS TREATED WITH PERSANTIM IV. PT. NOTED NEXT DAY TO HAVE SOME DEPENDENT CYANOSIS WHEN SITTING UP IN A CHAIR. THE EQUIPMENT APPEARED TO BE FUNCTIONING PROPERLY WHEN IN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCD DEVICE - SEQUEL SYSTEM SCD DEVICE JOW KENDALL VASCULAR THERAPY 9515 *

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention