BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOFRIC

    MDR report key: 14268178 · Received May 3, 2022

    Report

    Report Number
    3009632567-2022-00001
    Event Type
    Malfunction
    Date Received
    May 3, 2022
    Date of Event
    April 11, 2022
    Report Date
    April 15, 2022
    Manufacturer
    WELLSPECT HEALTHCARE(A DIVISION OF DENTSPLY IH AB)
    Product Code
    EZD
    UDI-DI
    07392532131813
    PMA / PMN Number
    K113424
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT COULD NOT PROVIDE THE DEVICE LOT. NO PRODUCTS OF THE ACTUAL BATCH HAVE BEEN RETURNED TO THE MANUFACTURER FOR INVESTIGATION. WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, WELLSPECT HEALTHCARE IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURRENCE. SHOULD ADDITIONAL FACTS PROMPT US TO ALTER OR SUPPLEMENT ANY INFORMATION OF CONCLUSIONS CONTAINED IN THIS REPORT, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    CUSTOMER REPORTED MODERATE BLEEDING FROM CATHETER USAGE AND TO REQUEST A DIFFERENT FRENCH SIZE. OUR CLINICAL NURSE, REACHED OUT TO THE PATIENT AND LEARNED HE WASN'T ACTIVATING LOFRIC CLASSIC (DRY CATHETER) PROPERLY. HE WAS USING A GEL LUBRICANT AND NOT SOAKING FOR 30 SECONDS WITH WATER ACCORDING TO PROVIDED INSTRUCTIONS FOR USE. HE WAS ALSO USING 18FR SAMPLES HE HAD LEFTOVER AT HOME. HIS REGULAR SHIPMENT IS FOR 16FR. HE SAID HE PREFERS USING A LOFRIC CATHETER WITH LUBRICANT (SALINE SOLUTION). WELLSPECT CUSTOMER SERVICE EMAILED THE PATIENT PRODUCT CATALOG, IFUS, MEN'S GUIDE AND INSTRUCTIONAL VIDEOS TO HELP HIM FIGURE IT OUT. THE PATIENT WAS ENCOURAGED TO CONTACT CUSTOMER SERVICE IF HE HAD ANY QUESTION ABOUT PRODUCT USAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1317619 LOFRIC LOFRIC NELATON 16 INCH, FR18 EZD WELLSPECT HEALTHCARE(A DIVISION OF DENTSPLY IH AB) 40018 07392532131813

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other