BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TBD

    MDR report key: 6329946 · Received February 14, 2017

    Report

    Report Number
    3007966929-2017-00005
    Event Type
    Malfunction
    Date Received
    February 14, 2017
    Product Code
    FFG
    PMA / PMN Number
    EXEMPT
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BRAND NAME: UNOMETER SAFETI. COMMON DEVICE NAME: DEVICE URINE FLOW RATE MEASURING, NON-ELECTRICAL). PRO-CODE: FFG). (B)(6). BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A PRODUCT MALFUNCTION. NO PATIENT HARM WAS REPORTED. ADDITIONAL DETAILS HAVE BEEN REQUESTED BUT NOT PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    A BATCH RECORD REVIEW WAS PERFORMED; AND A NON-CONFORMANCE (NC) FROM A PREVIOUS COMPLAINT WAS OPENED WHICH IS ASSOCIATED WITH THIS REPORTED ISSUE. THE NC HAS BEEN CLOSED AND NO FURTHER INVESTIGATION IS REQUIRED. THE INVESTIGATION CONCLUDED THAT THE LIKELY ROOT CAUSE FOR THE ISSUE, "STOP FLOW BETWEEN PATIENT AND CHAMBER OF THE UNOMETER PRODUCT" CANNOT BE IDENTIFIED BASED ON THE INFORMATION RECEIVED. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS. NO ADDITIONAL PATIENT/DETAILS HAS BEEN PROVIDED REGARDING THE REPORTED EVENT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AT A LATER DATE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    COMPLAINT REPORTED BY A DOCTOR THAT "THE URINE DID NOT FLOW INTO THE COLLECTION ROOM" OF THE DEVICE. THE DEVICE WAS REMOVED. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113473 TBD FFG 509047 227856

    Patients

    Seq Age Sex Outcome Treatment
    1