BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUREWICK FEMALE EXTERNAL CATHETER

    MDR report key: 8575561 · Received May 2, 2019

    Report

    Report Number
    1018233-2019-02295
    Event Type
    Injury
    Date Received
    May 2, 2019
    Report Date
    July 3, 2019
    Manufacturer
    PUREWICK CORPORATION ¿ 3012224959
    Product Code
    NZU
    UDI-DI
    00801741143083
    PMA / PMN Number
    EXEMPT
    Adverse Event
    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 OF THE REPORTED EVENT COULD BE THAT THE MATERIALS OF CONSTRUCTION WERE NOT BIOCOMPATIBLE WITH THE PATIENT DUE TO WHICH THERE WAS AN ALLERGIC REACTION, RESULTING IN SEVERE UTI. 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: "NOT RECOMMENDED FOR USE ON PATIENTS WITH A KNOWN LATEX ALLERGY." 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. H3 OTHER TEXT : THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN ALLERGIC REACTION AND A SEVERE URINARY TRACT INFECTION (UTI) WHILE USING THE LATEX WICKS. THE PATIENT WAS REPORTEDLY PRESCRIBED BACTRIM AND CIPROFLOXACIN TO TREAT THE UTI AND WAS ON NIGHTLY PERITONEAL DIALYSIS. THE PATIENT REPORTEDLY DISCONTINUED USE OF THE LATEX WICKS.

    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 PATIENT DEVELOPED AN ALLERGIC REACTION AND A SEVERE URINARY TRACT INFECTION (UTI) WHILE USING THE LATEX WICKS. THE PATIENT WAS REPORTEDLY PRESCRIBED BACTRIM AND CIPROFLOXACIN TO TREAT THE UTI AND WAS ON NIGHTLY PERITONEAL DIALYSIS. THE PATIENT REPORTEDLY DISCONTINUED USE OF THE LATEX WICKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365326 PUREWICK FEMALE EXTERNAL CATHETER PUREWICK FEMALE EXTERNAL NZU PUREWICK CORPORATION ¿ 3012224959 UNK 00801741143083

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention