BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STREAMLINE VASCULAR ACCESS DEVICE

    MDR report key: 34429 · Received July 24, 1996

    Report

    Report Number
    MW1009560
    Event Type
    Injury
    Date Received
    July 24, 1996
    Date of Event
    July 2, 1996
    Report Date
    July 3, 1996
    Manufacturer
    MENLO CARE, INC.
    Product Code
    FOZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    INSERTION OF PERIPHERAL IV CATHETER. WITHIN 3-5 MIN SYSTEMIC RESPONSE ERYTHEMA, URTICARIA AND LARGE WHEALS, C/O HEAD AND NECK CONGESTION. RASH ALL OVER. SWELLING OF EARS, LIPS, ARMS WHICH SPREAD RAPIDLY. IMMEDIATELY REMOVED CATHETER. NOTIFIED DR. RX BENADRYL 50MG IV (2 DOSES) AT 1525 AND 1900 HRS AND L2 BY CANNULAE. DISCHARGED NEXT DAY 7/3/96 AT 0930 - SKIN CLEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STREAMLINE VASCULAR ACCESS DEVICE PERIPHERAL INTRAVENOUS CATHETER FOZ MENLO CARE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention