BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URINARY DRAINAGE BAGS

    MDR report key: 3802015 · Received February 12, 2014

    Report

    Report Number
    3005778470-2014-00004
    Event Type
    Malfunction
    Date Received
    February 12, 2014
    Date of Event
    January 17, 2014
    Report Date
    January 20, 2014
    Manufacturer
    UNOMEDICAL S.R.O.
    Product Code
    FCN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. AN E-MAIL REQUESTING ADDITIONAL INFORMATION WAS SENT TO THE COMPLAINANT ON (B)(6) 2014, AND THE RESPONSE WAS RECEIVED (B)(4) 2014 AS THERE WAS A NEW DEVICE WITH A DIFFERENT LOT WAS REINSERTED; NO MEDICAL TREATMENT REQUIRED FOR PATIENT AND NO MEDICAL INFORMATION REGARDING PATIENT COULD BE PROVIDED. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. A RETURN SAMPLE FOR EVALUATION IS NOT EXPECTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    URINE WON'T DRAIN INTO THE BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92795 URINARY DRAINAGE BAGS KIT, URINARY DRAINAGE COLLECTION FCN UNOMEDICAL S.R.O. 48-110-1S-20 466855

    Patients

    Seq Age Sex Outcome Treatment
    1