BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOFRIC PRIMO

    MDR report key: 3594719 · Received January 13, 2014

    Report

    Report Number
    3009632672-2014-00040
    Event Type
    Injury
    Date Received
    January 13, 2014
    Report Date
    December 10, 2013
    Manufacturer
    WELLSPECT HEALTHCARE A DIVISION OF DENTSPLY IH AB
    Product Code
    EZD
    PMA / PMN Number
    K122078
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH DOCUMENTATION HAS BEEN ANALYZED AND REVEALS NO DEFECTS OR DEVIATIONS RELEVANT TO THIS COMPLAINT. THE PRODUCT WAS NOT AVAILABLE TO BE RETURNED. WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, WELLSPECT HC IS PRECLUDED FROM COMMUNICATING ON THE CONDITIONS OF THE DEVICE OR CAUSE OF THE OCCURRENCE. SHOULD THE DEVICE OR ADD'L INFO BE REC'D, A F/U REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINS HE HAD AN ALLERGIC REACTION DUE TO CATHETERIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34234 LOFRIC PRIMO CATHETER, STRAIGHT (EZD) EZD WELLSPECT HEALTHCARE A DIVISION OF DENTSPLY IH AB 41012 133512

    Patients

    Seq Age Sex Outcome Treatment
    1 Other