BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URINE SPECIMEN COLLECTOR

    MDR report key: 24042 · Received July 7, 1995

    Report

    Report Number
    24042
    Event Type
    Malfunction
    Date Received
    July 7, 1995
    Date of Event
    March 5, 1995
    Report Date
    March 14, 1995
    Manufacturer
    MARK CLARK INDUSTRIES
    Product Code
    FOC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    URINE SPECIMEN COLLECTOR BAG WAS USED TO OBTAIN A SPECIMEN FROM A NEWBORN. DURING THE TIME THE SPECIMEN BAG WAS IN PLACE THE PT DEVELOPED ERYTHEMATOUS IRRITATION TO THE PERINEUM TO THE DEGREE THAT IT WOULD BE CONSIDERED A HIGH RISK POTENTIAL FOR AN INFECTIOUS PROCESS. THE PT WAS DISCHARGED TO HOME WITH PERINEAL INSTRUCTIONS GIVEN TO THE PARENTS AND ALL URINE SPECIMEN BAGS WERE PULLED AND RETURNED TO THE MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 URINE SPECIMEN COLLECTOR URINE SPECIMEN COLLECTOR FOC MARK CLARK INDUSTRIES PEDI BAG

    Patients

    Seq Age Sex Outcome Treatment
    1 3 DAY