BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUREWICK FEMALE EXTERNAL

    MDR report key: 8654849 · Received May 30, 2019

    Report

    Report Number
    1018233-2019-02828
    Event Type
    Malfunction
    Date Received
    May 30, 2019
    Report Date
    July 24, 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: ¿CHECK PATIENT TUBING FOR BLOCKAGE OR FLOW RESTRICTION SUCH AS PINCHED OR KINKED TUBING¿. CORRECTION: D10. H11: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 DRYDOC SUCTION WAS TOO STRONG. NO MEDICAL INTERVENTION WAS REPORTED.

    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 DRYDOC SUCTION WAS TOO STRONG. NO MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449433 PUREWICK FEMALE EXTERNAL DRYDOC STATION NZU PUREWICK CORPORATION ¿ 3012224959 UNK 00801741151781

    Patients

    Seq Age Sex Outcome Treatment
    1