BEUDAMED
    FDA Adverse Event Other Summary report: N

    NEPHRETECT

    MDR report key: 40919 · Received August 30, 1996

    Report

    Report Number
    1221361-1996-00001
    Event Type
    Other
    Date Received
    August 30, 1996
    Date of Event
    August 28, 1996
    Report Date
    August 29, 1996
    Manufacturer
    ALDEN SCIENTIFIC, INC.
    Product Code
    HZT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT WAS PREPARED FOR DIALYSIS AND AT THE ONSET OF DIALYSIS EXPERIENCED A REACTION, AND DIALYSIS WAS DISCONTINUED. TYPICAL SYMPTOMS OF REBOUND SYNDROME OCCURRED WITH A DROP IN BLOOD PRESSURE, DIZZINESS, AND PT LAPSED INTO A SEMI-CONSCIOUS STATE. BENADRYL WAS ADMINISTERED AND WITHIN 4-5 MINUTES, SYMPTOMS HAD SUBSIDED, BUT PT WAS ADMITTED INTO HOSP FOR OBSERVATION. NO FURTHER DEVELOPMENTS OCCURRED. IN DISCUSSING THE INCIDENT WITH THE CHIEF TECHNICIAN IT WAS BELIEVED THAT THE RINSING PROCEDURE WAS NOT FULLY FOLLOWED. CHIEF TECHNICIAN TESTED THE LOT TO DETERMINE ITS EFFICACY AND IT PROVED TO BE WITHIN SPECS. CO WILL TEST SEVERAL AMPULES FROM THE EFFECTED LOT AND SUBMIT THE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEPHRETECT FORMALDEHYDE DETECTOR HZT ALDEN SCIENTIFIC, INC. NA 06728

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other