BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUREWICK FEMALE EXTERNAL

    MDR report key: 8197190 · Received December 26, 2018

    Report

    Report Number
    1018233-2018-06165
    Event Type
    Malfunction
    Date Received
    December 26, 2018
    Report Date
    February 15, 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 DEVICE WAS NOT RETURNED FOR EVALUATION. 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: ¿FOR USE WITH THE PUREWICK¿ FEMALE EXTERNAL CATHETER". 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 INSTRUCTION MANUAL WAS MISSING FROM THE DRYDOC MACHINE.

    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 INSTRUCTION MANUAL WAS MISSING FROM THE DRYDOC MACHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1037029 PUREWICK FEMALE EXTERNAL PUREWICK DRYDOC STATION NZU PUREWICK CORPORATION ¿ 3012224959 NA 00801741151781

    Patients

    Seq Age Sex Outcome Treatment
    1