BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEPHRETECT

    MDR report key: 333857 · Received May 17, 2001

    Report

    Report Number
    1221361-2001-00002
    Event Type
    Injury
    Date Received
    May 17, 2001
    Date of Event
    April 18, 2001
    Report Date
    April 18, 2001
    Manufacturer
    ALDEN, A DIV OF METREX RESEARCH CORP
    Product Code
    HZT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A HEALTHCARE WORKER FROM THE KIDNEY CENTER REPORTED THAT WHILE 2 PTS WERE HOOKED UP TO DIALYSIS TREATMENT, THEY SIMULTANEOUSLY EXPERIENCED SYMPTOMS OF FORMALDEHYDE EXPOSURE (IE, SWOLLEN LIPS, DIFFICULTY BREATHING). THE DIALYSIS TREATMENTS WERE IMMEDIATELY DISCONTINUED AND THE PTS RECEIVED MEDICAL TREATMENT FROM THE NURSES ON-SITE. THE HEALTHCARE WORKER STATED THAT PRIOR TO TURNING ON THE DIALYSIS MACHINES, NEPHRETECT WAS USED TO DETECT FORMALDEHYDE RESIDUAL. NO RESIDUAL WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23353 NEPHRETECT FORMALDEHYDE TEST REAGENT HZT ALDEN, A DIV OF METREX RESEARCH CORP UNK 00117

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Life Threatening