BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOFRIC PRIMO

    MDR report key: 10703665 · Received October 20, 2020

    Report

    Report Number
    3009632672-2020-00012
    Event Type
    Injury
    Date Received
    October 20, 2020
    Report Date
    October 20, 2020
    Manufacturer
    WELLSPECT HEALTHCARE, A DIVISION OF DENTSPLY IH AB
    Product Code
    EZD
    UDI-DI
    07392532131615
    PMA / PMN Number
    K122078
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    URINARY CATHETERIZATION THERAPY IS ASSOCIATED WITH AN INCREASED RISK OF URETHRAL BLEEDING, WHICH NORMALLY IS MILD AND TRANSIENT WITHOUT MEDICAL INTERVENTION. IN PATIENTS TREATED WITH ANTICOAGULANTS (AC) THE RISK OF PROLONGED BLEEDING IS INCREASED, WHICH IS WELL KNOWN BY BOTH THE PATIENTS AND HEALTH CARE PROFESSIONALS. IN THIS CASE, THE PATIENT WAS ON AC TREATMENT, AND THIS MAY HAVE CONTRIBUTED TO THE BLEEDING. IT HAS NOT BEEN POSSIBLE TO INVESTIGATE ANY PRODUCTS, AS NO PRODUCTS OF THE ACTUAL LOT HAVE BEEN RETURNED TO THE MANUFACTURER. THE REVIEW OF THE PRODUCTION BATCH RECORDS DID NOT SHOW ANY RELEVANT DEVIATIONS OR COMPLAINTS REGISTERED FOR THIS LOT. WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, (B)(6) 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 · 1

    THE PATIENT RECEIVED ANOTHER MODEL OF URINARY CATHETER THAN HE WAS PRESCRIBED (PATIENT RECEIVED A 40 CM CATHETER SIZE 12FR COUDE TIP, INSTEAD OF THE PRESCRIBED 40 CM CATHETER SIZE 16FR STRAIGHT TIP), DUE TO A MISTAKE WHEN THE PRODUCTS WERE DELIVERED FROM THE WAREHOUSE. THE LABELLING INFORMATION FOR THE DELIVERED PRODUCTS WAS CORRECT. THE PATIENT NOTICED THAT THE PACKAGE WAS DIFFERENT, BUT USED THE DELIVERED PRODUCTS ANYWAY AND EXPERIENCED A BLEEDING DURING THE URINARY CATHETERIZATION PROCEDURE. THE DAY AFTER, THE PATIENT HAD AN ALREADY SCHEDULED APPOINTMENT AT THE DOCTOR, AND AT THAT TIME THERE WAS NO BLEEDING. THE NEXT DAY THE BLEEDING RESUMED, AND THE PATIENT REVISITED THE DOCTOR. THE PATIENT RECEIVED A FOLEY CATHETER TO HAVE IN PLACE FOR AT LEAST TWO WEEKS. NO OTHER MEDICAL COMPLICATIONS ARE REPORTED, NO HOSPITALIZATION WAS NEEDED. THE PATIENT TAKES ANTICOAGULANT TREATMENT. THE OVERALL CONDITION FOR THE PATIENT WAS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1168224 LOFRIC PRIMO CATHETER, STRAIGHT EZD WELLSPECT HEALTHCARE, A DIVISION OF DENTSPLY IH AB 41512 429335 07392532131615

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other