BEUDAMED
    FDA Adverse Event Injury Summary report: N

    H/S CATHETER SET

    MDR report key: 96210 · Received June 5, 1997

    Report

    Report Number
    MW1011400
    Event Type
    Injury
    Date Received
    June 5, 1997
    Date of Event
    May 20, 1997
    Report Date
    June 5, 1997
    Manufacturer
    ACKRAD LABORATORIES, INC.
    Product Code
    MOV
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AR, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    INVESTIGATION OF EVENT STRONGLY INDICATES THAT THE H/S CATHETER IN QUESTION WAS IN NO WAY CONTRIBUTORY TO THE ADVERSE REACTION: 1. THERE WERE NO SYMPTOMS UNTIL THE CONTRAST MATERIAL WAS INTRODUCED AND THE CATHETER REMOVED. 2. ALLERGIC OR REACTIONS TO OSMOTIC EFFECTS ARE WELL KNOWN IN RADIOLOGY; THERE HAVE BEEN NO PREVIOUS REPORTS OF SUCH A REACTION WITH THIS PRODUCT IN MORE THAN 500,000 PROCEDURES. 3. IN A SEPARATE TELEPHONE CONVERSATION WITH THE REPORTER, IT WAS DISCLOSED THAT THE PT WAS EXTREMELY TENSE BEFORE THE PROCEDURE EVEN BEGAN.

    Description of Event or Problem · 1

    INVESTIGATION OF EVENT STRONGLY INDICATES THAT THE H/S CATHETER IN QUESTION WAS IN NO WAY CONTRIBUTORY TO THE ADVERSE REACTION: 1. THERE WERE NO SYMPTOMS UNTIL THE CONTRAST MATERIAL WAS INTRODUCED AND THE CATHETER REMOVED. 2. ALLERGIC OR REACTIONS TO OSMOTIC EFFECTS ARE WELL KNOWN IN RADIOLOGY; THERE HAVE BEEN NO PREVIOUS REPORTS OF SUCH A REACTION WITH THIS PRODUCT IN MORE THAN 500,000 PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 H/S CATHETER SET H/S CATHETER SET FOR HYSTEROSALPINGOGRAPHY MOV ACKRAD LABORATORIES, INC. NA 6076

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR