BEUDAMED
    FDA Adverse Event Other Summary report: N

    RENALIN

    MDR report key: 12572 · Received April 4, 1994

    Report

    Report Number
    MW1001463
    Event Type
    Other
    Date Received
    April 4, 1994
    Date of Event
    March 10, 1994
    Report Date
    March 14, 1994
    Manufacturer
    MINNTECH CORP.
    Product Code
    LIF
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HEMODIALYSIS TREATMENT INITIATED. WITHIN 10 MINUTES PT COMPLAINED OF SHORTNESS OF BREATH, CHEST PAIN AND STINGING SENSATION THROUGHOUT HIS BODY. TREATMENT WAS DISCONTINUED, OXYGEN APPLIED AND PT PLACED ON THE HEART MONITOR. DR WAS NOTIFIED. BLOOD PRESSURE WAS 140/90, PULSE 120. PT WAS SENT TO THE HOSP FOR AN OUTPATIENT HEMODIALYSIS TREATMENT WHICH WAS COMPLETED WITHOUT PROBLEM. PT IS ON A REGULAR MAINTENANCE DIALYSIS PROGRAM AND HAS HAD NO FURTHER PROBLEMS. (ALSO SEE 1001462.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENALIN * LIF MINNTECH CORP. * 96522

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other