BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOFRIC PRIMO

    MDR report key: 5110179 · Received September 29, 2015

    Report

    Report Number
    3009632672-2015-00012
    Event Type
    Malfunction
    Date Received
    September 29, 2015
    Report Date
    September 18, 2015
    Manufacturer
    WELLSPECT HEALTHCARE, A DIVISION OF DENTSPLY IH AB
    Product Code
    EZD
    PMA / PMN Number
    K122078
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT WAS NOT AVAILABLE TO BE RETURNED. WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, WELLSPECT HEALTHCARE IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF OCCURRENCE. THE BATCH DOCUMENTATION SHOWED NO DEVIATIONS AND ANY OTHER COMPLAINT ON THIS LOT HAS NOT BEEN RECEIVED. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THE REPORTER STATES THAT THE CATHETER IS MISSING DRAINAGE HOLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641716 LOFRIC PRIMO CATHETER, STRAIGHT EZD WELLSPECT HEALTHCARE, A DIVISION OF DENTSPLY IH AB 41012 170854

    Patients

    Seq Age Sex Outcome Treatment
    1