BEUDAMED
    FDA Adverse Event Death Summary report: N

    IN-FED

    MDR report key: 19123 · Received June 20, 1994

    Report

    Report Number
    2243621-1994-05111
    Event Type
    Death
    Date Received
    June 20, 1994
    Date of Event
    May 28, 1994
    Report Date
    June 1, 1994
    Manufacturer
    SCHEIN PHARMACEUTICAL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS PT COMPLAONED OF NOT FEELING WELL DURING A TEST DOSE (25MG) OF IN-FED. BP DOWN TO 42/P. NORMAL SALINE STARTED. IN-FED DOSE STOPPED. THE PT LOST CONSCIOUSNESS AND THEN BECAME RESPONSIVE BRIEFLY. BEFORE AGAIN BECOMMING NON-RESPONSIVE AND APNEIC. CPR WAS INITIATED AND SHE WAS SUCTIONED. 911 AND THE PHYSICIAN WERE CALLED. CPR CONTINUED AND THE RESCUE ARRIVED. THEIR FIRST ATTEMPT AT INTUBATION WAS UNSUCCESSFUL BUT THE SECOND ATTEMPT WAS SUCCESSFUL. THE PT WAS THEN TRANSPORTED TO THE ER. SHE WAS NON-RESPONSIVE WHEN SHE LEFT THE UNIT.THE PT EXPIRED AT THE HOSPITAL ON 5/30/94. THE PHYSICIAN WAS UNSURE OF CAUSE OF DEATH. THIS WAS THE START OF THE SECOND COURSE OF IN-FED FOR THIS PT. HER FIORST COURSE WAS ON 12/22/93.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IN-FED SCHEIN PHARMACEUTICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death| H