BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ AC AND SUPER XL ENEMA KIT

    MDR report key: 759 · Received June 22, 1992

    Report

    Report Number
    759
    Event Type
    Injury
    Date Received
    June 22, 1992
    Date of Event
    May 27, 1992
    Report Date
    June 5, 1992
    Manufacturer
    E-Z-EM, INC.
    Product Code
    FGD
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD BARIUM ENEMA W/AIR-BECAME FLUSHED & STUFFY NOSE. HARD TO SWALLOW-UP TO PR-NOSE RUNNY. THEN COUGH-HIVES WHEEZY VISITED BY DR. EPI .35C & BENADRYL 50 MG IV - NS 500 BACK OPEN USS BP 130/72 P 96DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: A DEVICE FROM SAME LOT WAS EVALUATED, OTHER. RESULTS OF EVALUATION: NONE OR UNKNOWN, ANTICIPATED ADVERSE REACTION - SHORT TERM. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EZ AC AND SUPER XL ENEMA KIT BARIUM ENEMA PRODUCTS FGD E-Z-EM, INC. SAME (EZAC LE2031)SUPER XL05228925

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other