BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOFRIC ORIGO

    MDR report key: 10348922 · Received July 31, 2020

    Report

    Report Number
    3009632672-2020-00008
    Event Type
    Malfunction
    Date Received
    July 31, 2020
    Date of Event
    June 15, 2020
    Report Date
    July 31, 2020
    Manufacturer
    WELLSPECT HEALTHCARE, A DIVISION OF DENTSPLY IH AB
    Product Code
    EZD
    PMA / PMN Number
    K122078
    Removal / Correction Number
    Z-2644-2020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT COULD NOT CATHETERIZE AS A POTENTIAL RESULT OF USING CATHETERS WITH MALFORMATION OF THE TIPS CAUSING TRAUMA. EVEN THOUGH THE USED PRODUCT WAS NOT AVAILABLE FOR RETURN, AND RECALLED PRODUCTS SAMPLES FROM SAME LOT HAS NOT BEEN POSSIBLE TO ANALYSE IT CANNOT BE EXCLUDED THE EVENT WAS CAUSED BY THE PRODUCT QUALITY PROBLEM BEHIND THE ONGOING RECALL (Z-2644-2020)

    Description of Event or Problem · 1

    ACCORDING TO INFORMATION A FEMALE USER IN (B)(6) HAS USED A LOFRIC ORIGO TIEMANN (CURVED TIP) URINARY CATHETER, WHICH IS INTENDED FOR INTERMITTENT CATHETERIZATION TO EMPTY HER POUCH. THE FEMALE PATIENT CLAIMED THAT SHE HAD TO GO TO THE EMERGENCY ROOM OF THE (B)(6) ON (B)(6) DUE TO SEVERE PROBLEMS, AS THE POUCH COULD NO LONGER BE CATHETERIZED! AT UKSH SHE RECEIVED A PERMANENT INDWELLING CATHETER. UNTIL (B)(6) SHE USED AT LEAST 1 CARTON (30 PIECES) OF THE LOFRIC ORIGO URINARY CATHETER WHICH IS CURRENTLY INCLUDED IN AN ONGOING RECALL. SHE ONCE HAD A MINOR BLEEDING. ON (B)(6) SHE WAS INFORMED BY A LETTER SEND BY THE MEDICAL DEVICE RETAILER (NOMA MED) THAT WELLSPECT HEALTHCARE, LEGAL MANUFACTURER OF LOFRIC ORIGO HAS INITIATED A FIELD SAFETY NOTICE (RECALL LETTER), TO RECALLS CERTAIN LOT. NUMBERS OF LOFRIC ORIGO CATHETERS. THE FEMALE PATIENT STATES "IT SEEMS TO BE CLEAR IN TIME THAT MY SEVERE COMPLAINTS WERE CAUSED BY THE USE OF THE FAULTY CATHETERS". THE PATIENT HEALTH IS CURRENTLY GOOD, AND SHE IS USING A PERMANENT INDWELLING CATHETER UNTIL (B)(6). THEREAFTER SHE WILL TRY TO USE THE SELF-CATHETERISATION AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    813616 LOFRIC ORIGO LOFRIC ORIGO, TIEMANN, 16 IN., FR12 EZD WELLSPECT HEALTHCARE, A DIVISION OF DENTSPLY IH AB 44412 450422

    Patients

    Seq Age Sex Outcome Treatment
    1 Other