BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOFRIC PRIMO

    MDR report key: 10090929 · Received May 27, 2020

    Report

    Report Number
    3009632672-2020-00005
    Event Type
    Injury
    Date Received
    May 27, 2020
    Date of Event
    April 10, 2020
    Report Date
    May 27, 2020
    Manufacturer
    WELLSPECT HEALTHCARE, A DIVISION OF DENTSPLY IH AB
    Product Code
    EZD
    UDI-DI
    07392532131615
    PMA / PMN Number
    K122078
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE IS DISCARDED. THE MANUFACTURED HAS ASKED FOR UNUSED SAMPLES FROM THE SAME LOT NUMBER TO BE RETURNED FOR EVALUATION, BUT NO SAMPLES HAVE BEEN RETURNED. THE REVIEW OF THE BATCH RECORDS FOR THE AFFECTED LOT NUMBER SHOWED NO DEVIATION THAT CAN EXPLAIN THE INCIDENT. WITHOUT THE BENEFIT OF EXAMINATION AND TESTING THE DEVICE, THE MANUFACTURER 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 THE ORIGINAL MDR REPORT, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE EVENT OCCURRED IN (B)(6), I.E. OUTSIDE USA. ACCORDING TO COMPLAINT REPORT THE PATIENT INJURED THE URETHRA AND EXPERIENCED A MINOR BLEEDING DURING THE CATHETERIZATION PROCEDURE. THE PATIENT, WHO IS SAID TO BE AN EXPERIENCED USER OF URINARY CATHETERS HAD DESCRIBED THAT THERE WAS A SMALL PLASTIC PART ON THE TIP OF THE CATHETER WHICH GOT STUCK IN THE URETHRA. THE PATIENT HAD SAID HE REMOVED THE SMALL PLASTIC PART BY "PUSHING AND PULLING ON IT", BY HIMSELF. A MINOR BLEEDING WAS NOTICED AND THE PATIENT MET A DOCTOR AND WAS GIVEN AN INDWELLING CATHETER WHILE HEALING. THE FOLLOWING DAY THE PATIENT WAS DISCHARGED, AND IN GOOD HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556059 LOFRIC PRIMO CATHETER, STRAIGHT EZD WELLSPECT HEALTHCARE, A DIVISION OF DENTSPLY IH AB 41512 445572 07392532131615

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O