BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDIATRIC URINE COLLECTOR BAG

    MDR report key: 10042468 · Received May 11, 2020

    Report

    Report Number
    10042468
    Event Type
    Malfunction
    Date Received
    May 11, 2020
    Date of Event
    April 15, 2020
    Report Date
    April 23, 2020
    Manufacturer
    PRECISION DYNAMICS CORPORATION
    Product Code
    EXI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    I OPENED THE STERILE PEDIATRIC URINE COLLECTOR BAG WITH LOT # 080208 AND THERE IS A LONG SLIT ALONG THE EDGE OF THE BAG SO IT IS DEFECTIVE AND NOT USABLE. THE BAG WAS USED ON THE PATIENT WHILE IN THEIR HOME FOR URINE COLLECTION, LUCKILY THEY HAD ANOTHER ONE ON HAND OR ELSE THIS WOULD HAVE CAUSED A GREAT DEAL OF DELAY OF CARE SINCE THEY WOULD HAVE TO RETURN TO CLINIC TO PICK UP ANOTHER SUPPLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507806 PEDIATRIC URINE COLLECTOR BAG DEVICE, PASTE-ON FOR INCONTINENCE, STERILE EXI PRECISION DYNAMICS CORPORATION 080208

    Patients

    Seq Age Sex Outcome Treatment
    1