BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOFRIC PRIMO

    MDR report key: 5103477 · Received September 25, 2015

    Report

    Report Number
    3009632672-2015-00011
    Event Type
    Malfunction
    Date Received
    September 25, 2015
    Report Date
    September 17, 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

    SAMPLES WERE RETURNED BY THE CUSTOMER AND BY ANALYSIS, MISSING DRAINAGE HOLE WAS FOUND. THE BATCH DATA WAS ALSO ANALYZED AND SHOWED NO DEVIATIONS. NO OTHER COMPLAINTS HAVE BEEN RECEIVED ON THIS LOT.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE CATHETER MISSED DRAINAGE HOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634085 LOFRIC PRIMO CATHETER, STRAIGHT EZD WELLSPECT HEALTHCARE, A DIVISION OF DENTSPLY IH AB 41012 173705

    Patients

    Seq Age Sex Outcome Treatment
    1