BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPRESSAR SYSTEM

    MDR report key: 209689 · Received February 2, 1999

    Report

    Report Number
    209689
    Event Type
    Injury
    Date Received
    February 2, 1999
    Date of Event
    January 25, 1999
    Report Date
    January 27, 1999
    Manufacturer
    SEMLER TECHNOLOGIES, INC.
    Product Code
    DXC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON 1/25/1999 PT HAD ANGIOGRAM AND WAS RETURNED TO CARDIOLOGY UNIT. WHEN ACTIVATED CLOTTING TIME LEVEL DETERMINED TO MEET CRITERIA (ACT 137) SHEATH TO BE PULLED FROM GROIN. C-CLAMP AND COMPRESSAR DISC IN PLACE AND TO BE RELEASED TO PULL SHEATH. WHEN RELEASING DEVICES COMPRESSAR DISC CRACKED AND DISINTEGRATED. THIS APPARENTLY CAUSED IRRITATION TO CLOTTED VESSEL WHICH CAUSED BLEEDING AND THE DEVELOPMENT OF A HEMATOMA. MANUAL PRESSURE APPLIED. NO FURTHER INTERVENTION REQUIRED BUT PT HAS HEMATOMA AND LARGE AREA OF ECCHYMOSIS. ALL DEVICES WITH SUSPECTED LOT NUMBERS PULLED AND REPLACED BY MFR ON 1/26/1999.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPRESSAR SYSTEM DISPOSAL COMFORT DISC DXC SEMLER TECHNOLOGIES, INC. 5187 C149LG8

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention