BEUDAMED
    FDA Adverse Event Injury Summary report: N

    URIPLAN LEG BAG DRUG TARIFF

    MDR report key: 4941871 · Received July 23, 2015

    Report

    Report Number
    1018233-2015-00233
    Event Type
    Injury
    Date Received
    July 23, 2015
    Report Date
    July 3, 2015
    Manufacturer
    PRODUCTOS PARA EL CUIDADO DE LA SALUD
    Product Code
    KNX
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    RECEIVED ONE USED URIPLAN LEG BAG. VISUAL INSPECTION OF THE BAG, NOTED THE DRAINAGE TUBE HAD SOME TYPE OF STICKY SUBSTANCE ON ALL SURFACES. THE BAG WAS INSPECTED FURTHER FOR ANY IMPERFECTIONS AND NONE WERE SEEN. ON THE BAGS WHITE VINYL IT WAS NOTED THAT WERE SECTIONS THAT APPEAR DIRTY. THE USED BAG WAS TESTED UNDER WATER AND NO LEAKAGE WAS FOUND THAT COULD HAVE CAUSED URINE TO COME IN CONTACT WITH THE USER AND CONTRIBUTE TO THE RASH. A TACTILE EVALUATION WAS CONDUCTED, THE ENTIRE SURFACE AND SEAL EDGE OF THE DRAINAGE BAG WAS REVIEWED AND TOUCHED WITH FINGERS AND NO PROTUBERANCES OR SHARP EDGES WERE FOUND. THE REPORTED EVENT WAS UNCONFIRMED, THE DEVICE MET SPECIFICATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE STATES THE FOLLOWING: "- THIS IS A SINGLE USE DEVICE. DO NOT RESTERILIZE ANY PORTION OF THIS DEVICE. REUSE AND/OR REPACKAGING MAY CREATE A RISK OF PATIENT OR USER INFECTION, COMPROMISE THE STRUCTURAL INTEGRITY AND/OR ESSENTIAL MATERIAL AND DESIGN CHARACTERISTICS OF THE DEVICE, WHICH MAY LEAD TO DEVICE FAILURE, AND/OR LEAD TO INJURY, ILLNESS OR DEATH OF THE PATIENT. THE INSTRUCTIONS FOR USE PROVIDES INDICATIONS OF HOW TO WEAR THE LEG BAG DEPENDING ON WHICH SIZE OF BAG THE CUSTOMER PREFERS." (B)(4). THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAS EXPERIENCED A BURN ON HER LEFT SHIN THAT IS APPROXIMATELY 8CM WIDE AND 11 CM LONG. THE DISTRICT NURSE THINKS IT HAS BEEN CAUSED BY THE NIGHT BAG. THE PT IS BED BOUND AND HAD THE NIGHT BAG ON FOR 3 DAYS. THE PT ADVISED THE DISTRICT NURSE THAT THE BAG WAS BECOMING HOT ON HER LEG. ANTIBIOTICS HAVE BEEN PROVIDED AS THE BURN HAS CAUSED THE SKIN TO BREAK AND THERE IS AN INFECTION. THE PT HAS BEEN USING THESE NIGHT BAGS FOR OVER A YEAR WITH NO OTHER SIDE AFFECTS. NO MEDICATION HAS CHANGED. SPOKE TO THE PT MOTHER WHO ADVISED THAT THE PT WAS WEARING A URISLEEVE OVER THE BAG AND ADVISED THAT HER LEG WAS HUNTING. UPON REMOVAL OF THE LEG BAG SHE COULD SEE A RED MARK THAT WAS DESCRIBED AS LOOKING LIKE A BURN. SOME OF THE SKIN HAD COME AWAY AND THE PT WAS PROVIDED ANTIBIOTICS. THE NURSE AND DOCTOR LOOKED AT IT AND THOUGHT IT LOOKED LIKE A BURN. FLOCK BACKING HAS BEEN SENT TO THE PT AND THEY WIL BE PROVIDING AN IMAGE OF WHAT THE MARK LOOKED LIKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478055 URIPLAN LEG BAG DRUG TARIFF KNX PRODUCTOS PARA EL CUIDADO DE LA SALUD NA NGXC1046

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention