BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOFRIC ORIGO

    MDR report key: 6928075 · Received October 9, 2017

    Report

    Report Number
    3009632672-2017-00006
    Event Type
    Injury
    Date Received
    October 9, 2017
    Report Date
    September 27, 2017
    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

    ACCORDING TO THE REPORTER, WHICH WAS THE USER HIMSELF, HE EXPERIENCED A SLIGHT PAIN IN URETHRA DURING CATHETERIZATION ALONG WITH HEART PALPITATIONS DURING NIGHT-TIME FOLLOWING CATHETERIZATION, AND AT ONE OCCASION ATRIAL FIBRILLATION. IT IS UNCLEAR HOW THE ATRIAL FIBRILLATION WAS DIAGNOSED AND IF THE PATIENT DID SEEK MEDICAL ATTENTION OR REQUIRED ANY KIND OF TREATMENT. THIS REACTION COULD POTENTIALLY BE SOME KIND OF HYPERSENSITIVITY REACTION EVEN THOUGH THE TIME RELATION IN BETWEEN CATHETERIZATIONS AND ONSET OF HEART PALPITATION MAY INDICATE THAT MANIFESTATIONS IS UNRELATED TO USE OF THE DEVICE. OCCASIONAL ALLERGIC REACTIONS RELATED TO CATHETER USE HAVE BEEN REPORTED BUT NONE OF THESE EVENTS HAVE BEEN CONNECTED TO HEART PALPITATIONS AS DESCRIBED IN THE CURRENT COMPLAINT. THE CAUSE OF THIS EVENT HAS NOT BEEN DETERMINED AND IT CANNOT BE CONCLUDED IF THERE IS A RELATION TO THE LOFRIC ORIGO CATHETER OR IF THERE ARE OTHER CAUSES TO THIS EVENT. THE PRODUCTS WERE NOT RETURNED TO MANUFACTURER AND NO INFORMATION ABOUT THE LOT NUMBER WAS RECEIVED. WITHOUT THE BENEFIT OF EXAMINING AND TESTING THE USED DEVICES, WELLSPECT HEALTHCARE IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, WHICH WAS THE USER HIMSELF, HE FELT A CONTINUOUSLY SLIGHT PAIN IN THE URETHRA WHILE USING THE LOFRIC ORIGO CATHETER. THE NIGHT OF THE SECOND DAY OF USING LOFRIC ORIGO HE FELT PALPITATIONS. THE REPORTER HAD THE SAME EXPERIENCE AT TWO ADDITIONAL OCCASIONS. LATER, HE MADE AN ADDITIONAL ATTEMPT TO USE THE LOFRIC ORIGO AND ON THE SECOND DAY OF USE HE EXPERIENCED PALPITATIONS WHICH DEVELOPED TO ATRIAL FIBRILLATIONS FOR 10 TO 15 MINUTES, HOWEVER THIS IS NOT MEDICALLY CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711043 LOFRIC ORIGO CATHETER, STRAIGHT EZD WELLSPECT HEALTHCARE, A DIVISION OF DENTSPLY IH AB 44314

    Patients

    Seq Age Sex Outcome Treatment
    1 Other