BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    PUREWICK URINE COLLECTION SYSTEM

    MDR report key: 12035660 · Received June 21, 2021

    Report

    Report Number
    1018233-2021-03670
    Event Type
    Malfunction
    Date Received
    June 21, 2021
    Date of Event
    May 26, 2021
    Report Date
    September 1, 2021
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    NZU
    UDI-DI
    00801741185342
    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

    UPON FURTHER REVIEW, PER ADDITIONAL INFORMATION RECEIVED THIS EVENT IS NOT REPORTABLE. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL 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 WAS NOT CLEAR ON THE INSTRUCTIONS FOR SETUP OF THE PUREWICK URINE COLLECTION SYSTEM AND WAS UNABLE TO DETERMINE WHETHER IT WAS SET UP CORRECTLY. THE LIBERATOR MEDICAL SERVICE FOLLOW UP WITH CUSTOMER AND CONFIRMED THAT WAS CONNECTED PROPERLY AND THE SYSTEM WAS WORKING. PER FOLLOW UP VIA PHONE ON 28MAY2021 THE CUSTOMER STATED THAT THE PUREWICK WAS SET UP AND PASSED THE WATER TEST. ALSO STATED THAT THE PATIENT DID NOT USE THE PUREWICK YET BECAUSE THE PATIENT DID NOT NEED THE WATER PILL LAST NIGHT.

    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 WERE NOT CLEAR ON THE INSTRUCTIONS FOR SET UP OF THE PUREWICK URINE COLLECTION SYSTEM AND WERE UNABLE TO DETERMINE WHETHER IT WAS SET UP CORRECTLY. LIBERATOR MEDICAL SERVICE FOLLOW UP WITH CUSTOMER AND CONFIRMED THAT WAS CONNECTED PROPERLY AND THE SYSTEM WAS WORKING. PER FOLLOW UP VIA PHONE (B)(6) 2021, CUSTOMER STATES THE PUREWICK WAS NOW SET UP AND PASSED THE WATER TEST. CUSTOMER STATES THAT SHE HAS NOT USED THE PUREWICK YET BECAUSE SHE DID NOT NEED HER WATER PILL LAST NIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    931784 PUREWICK URINE COLLECTION SYSTEM PUREWICK URINE COLLECTION SYSTEM NZU C.R. BARD, INC. (COVINGTON) -1018233 PW100 NA 00801741185342

    Patients

    Seq Age Sex Outcome Treatment
    1 Other