BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URINE METER

    MDR report key: 7742432 · Received August 2, 2018

    Report

    Report Number
    3007966929-2018-00011
    Event Type
    Malfunction
    Date Received
    August 2, 2018
    Date of Event
    June 7, 2018
    Manufacturer
    UNOMEDICAL ZAVODSKAYA STREET 50
    Product Code
    FFG
    PMA / PMN Number
    EXEMPT
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMMON DEVICE NAME: DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE. PRODUCT CODE: FFG . (B)(6). BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN REQUESTED BUT NONE HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4)

    Additional Manufacturer Narrative · 1

    CORRECTED DEVICE MANUFACTURE DATE. A BATCH RECORD REVIEW WAS PERFORMED. NO NON ¿ CONFORMANCE REPORT RELATED TO COMPLAINT ISSUE(S) WERE INITIATED FOR THE COMPLAINT ORDER DURING PRODUCTION. IN ACCORDANCE WITH INFORMATION WITHIN THE COMPLAINT FILE, THE DEVICE WAS USED DURING EIGHT DAYS. IN ACCORDANCE WITH THE INFORMATION FOR THE UNOMETER, ¿THE RECOMMENDED USAGE TIME IS UP TO SEVEN DAYS¿. IT IS CUSTOMER MISUSE. NO MANUFACTURING FAILURE IS IDENTIFIED. NO SAMPLES WERE RECEIVED FOR THE COMPLAINT. A PICTURE WAS RECEIVED. ON THE BASE OF RECEIVED PICTURE IT IS IMPOSSIBLE TO MAKE A CLEAR DECISION RELATED TO STOP FLOW ISSUE. NO ADDITIONAL ACTION IS NEEDED. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A ¿URINARY STASIS IN THE DOUBLE LUMEN TUBE¿ ISSUE OCCURRED IN A TOTAL OF THREE (3) UNOMETER SAFETI-PLUS DEVICE (S). THERE WAS NO REPORTED PATIENT HARM. A PHOTOGRAPH DEPICTING THE REPORTED ISSUE WAS PROVIDED. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586959 URINE METER FFG UNOMEDICAL ZAVODSKAYA STREET 50 158100140190 307880

    Patients

    Seq Age Sex Outcome Treatment
    1