BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUREWICK FEMALE EXTERNAL

    MDR report key: 8562253 · Received April 29, 2019

    Report

    Report Number
    1018233-2019-02218
    Event Type
    Injury
    Date Received
    April 29, 2019
    Report Date
    June 27, 2019
    Manufacturer
    PUREWICK CORPORATION ¿ 3012224959
    Product Code
    NZU
    UDI-DI
    00801741151781
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. A POTENTIAL ROOT CAUSE COULD BE DUE TO "MECHANICAL MALFUNCTION". THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: "CHECK PATIENT TUBING FOR BLOCKAGE OR FLOW RESTRICTION SUCH AS PINCHED OR KINKED TUBING", WHICH CAN HELP PREVENT URINE BUILDUP IN THE PUREWICK CATHETER THAT COULD POTENTIALLY LEAD TO A UTI. THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED REPEATED URINARY TRACT INFECTIONS FROM USE OF THE DRYDOC STATION. THE PATIENT WAS TREATED WITH ANTIBIOTICS.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED REPEATED URINARY TRACT INFECTIONS FROM USE OF THE DRYDOC STATION. THE PATIENT WAS TREATED WITH ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356194 PUREWICK FEMALE EXTERNAL DRYDOC STATION NZU PUREWICK CORPORATION ¿ 3012224959 UNK 00801741151781

    Patients

    Seq Age Sex Outcome Treatment
    1 Other