BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUREWICK FEMALE EXTERNAL.

    MDR report key: 8118556 · Received November 29, 2018

    Report

    Report Number
    1018233-2018-05687
    Event Type
    Malfunction
    Date Received
    November 29, 2018
    Report Date
    February 13, 2019
    Manufacturer
    PUREWICK CORPORATION ¿ 3012224959
    Product Code
    NZU
    UDI-DI
    00801741151781
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT WAS CONFIRMED AS CAUSE UNKNOWN. THE INSTRUCTIONS FOR USE WERE NOT PRESENT IN THE PHOTO RECEIVED. THE PACKAGING WAS THE ORIGINAL PACKAGING. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: "WELCOME THANK YOU FOR PURCHASING THE DRYDOC¿ VACUUM STATION, THE VACUUM SUCTION TO BE USED WITH THE PUREWICK¿ FEMALE EXTERNAL CATHETER (¿PUREWICK¿ FEC¿). PLEASE READ ALL OPERATING INSTRUCTIONS, SAFETY INFORMATION, AND WARNINGS BEFORE FIRST USE OF THIS PRODUCT. FOR MORE INFORMATION, VISIT WWW.LIBERATORMEDICAL.COM/PUREWICK". SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD 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 BD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INSTRUCTIONS WERE MISSING FROM THE DRYDOC SHIPMENT WHEN THE CUSTOMER OPENED THE BOX.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSTRUCTIONS WERE MISSING FROM THE DRYDOC SHIPMENT WHEN THE CUSTOMER OPENED THE BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    957718 PUREWICK FEMALE EXTERNAL. PUREWICK DRYDOC STATION NZU PUREWICK CORPORATION ¿ 3012224959 NA 00801741151781

    Patients

    Seq Age Sex Outcome Treatment
    1