BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOFRIC SENSE

    MDR report key: 7132814 · Received December 20, 2017

    Report

    Report Number
    3009632672-2017-00007
    Event Type
    Injury
    Date Received
    December 20, 2017
    Report Date
    November 23, 2017
    Manufacturer
    WELLSPECT HEALTHCARE, A DIVISION OF DENTSPLY IH AB
    Product Code
    EZD
    UDI-DI
    07392532086366
    PMA / PMN Number
    K123751
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXAMINATION OF THE SIX RETURNED CATHETERS SHOWED THAT THE CATHETERS GOT STUCK TO THE PACKAGING. THE USER IS CONCERNED THAT THE DEVICE IS LINKED WITH AN INFECTION. THE MANUFACTURER HAS NOT BEEN ABLE TO ESTABLISH ANY RELATION BETWEEN THE DEVICE AND THE REPORTED HARM (INFECTION), BUT IT COULD NOT BE EXCLUDED THAT THERE IS A RELATIONSHIP BETWEEN THE DEVICE AND THE INFECTION. IT IS UNKNOWN WHETHER THE USER USED THE CATHETER OR NOT. THE MANUFACTURER HAS MADE UNSUCCESSFUL ATTEMPTS TO RECEIVE MORE INFORMATION REGARDING THIS INCIDENT AND THE SEVERITY OF INFECTION, BUT THE USER DOES NOT WANT TO PROVIDE ANY ADDITIONAL INFORMATION. NO ACTIONS ARE CONSIDERED TO BE REQUIRED. THIS TYPE OF DEFICIENCY IS CONSIDERED TO BE EASY TO DETECT PRIOR TO USE OF THE DEVICE. STERILIZATION DOSE HAS BEEN SUBSTANTIATED BY DOSE AUDITING STUDIES AND BIOBURDEN LEVELS ARE ROUTINELY MONITORED AND HAVE BEEN WITHIN SPECIFICATION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE CATHETER WAS STUCK TO THE FOIL IN THE PACKAGE AND UPON REMOVAL FROM THE PACKAGE, THE FOIL WAS PHYSICALLY REMOVED. THE USER IS CONCERNED THAT THIS COULD BE LINKED WITH AN INFECTION, BUT DOES NOT WANT TO PROVIDE ANY FURTHER INFORMATION REGARDING THIS INCIDENT. IT IS NOT KNOWN WHETHER THE USE USED THE CATHETER OR NOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    913542 LOFRIC SENSE CATHETER, STRAIGHT EZD WELLSPECT HEALTHCARE, A DIVISION OF DENTSPLY IH AB 41612 406116 07392532086366

    Patients

    Seq Age Sex Outcome Treatment
    1 Other