BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUREWICK URINE COLLECTION SYSTEM

    MDR report key: 11837936 · Received May 17, 2021

    Report

    Report Number
    1018233-2021-02860
    Event Type
    Malfunction
    Date Received
    May 17, 2021
    Date of Event
    April 23, 2021
    Report Date
    August 20, 2021
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    NZU
    UDI-DI
    00801741185359
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT IS INCONCLUSIVE AS NO SAMPLE WAS RETURNED FOR EVALUATION. A POTENTIAL ROOT CAUSE COULD BE DUE TO AN "MISS OUT TO PUT IN THE CARTON BOX". IT WAS UNKNOWN WHETHER THE DEVICE HAD MET SPECIFICATIONS. BASED ON PATIENT CODE 2645 THE PRODUCT DOES NOT APPEAR TO HAVE BEEN USED. HOWEVER, THE PRODUCT IS INTENDED TO BE USED FOR TREATMENT PURPOSE BUT IT WAS UNKNOWN WHETHER THE PRODUCT HAD CAUSED THE REPORTED FAILURE. THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. A LABELING REVIEW WAS NOT COMPLETED AS THE USER WOULD NOT LIKELY CAUSE THIS ISSUE. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BARD 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 BARD. H3 OTHER TEXT : THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PUREWICK URINE COLLECTION SYSTEM DID NOT COME WITH A USER MANUAL. LIBERATOR MEDICAL SERVICE WILL EMAIL MANUAL TO THE PATIENT'S DOCTOR.

    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 PUREWICK URINE COLLECTION SYSTEM DID NOT COME WITH A USER MANUAL. LIBERATOR MEDICAL SERVICE WILL MAIL THE MANUAL TO THE PATIENT'S DOCTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727784 PUREWICK URINE COLLECTION SYSTEM PUREWICK URINE COLLECTION SYSTEM NZU C.R. BARD, INC. (COVINGTON) -1018233 PW200 NA 00801741185359

    Patients

    Seq Age Sex Outcome Treatment
    1 Other