BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOFRIC HYDRO-KIT

    MDR report key: 10436437 · Received August 21, 2020

    Report

    Report Number
    3009632672-2020-00009
    Event Type
    Injury
    Date Received
    August 21, 2020
    Date of Event
    July 20, 2020
    Report Date
    August 21, 2020
    Manufacturer
    WELLSPECT HEALTHCARE, A DIVISION OF DENTSPLY IH AB
    Product Code
    EZD
    UDI-DI
    07392532142673
    PMA / PMN Number
    K122078
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER HAS INVESTIGATED THE BATCH RECORDS AND THE RETURNED PRODUCTS FROM THE ACTUAL LOT, AND PERFORMED A THROUGH INVESTIGATION BY MEANS OF SCRUTINIZING ALL STEPS IN THE MANUFACTURING PROCESS. THE MANUFACTURER HAS CONCLUDED THAT THIS TYPE OF CATHETER DAMAGE COULD NOT OCCUR IN THE MANUFACTURING PROCESS. THE MANUFACTURER HAS REVIEWED HISTORICAL INCIDENT DATA FOR PAST 10 YRS AND IS NOT AWARE OF ANY OTHER COMPLAINTS FOR THE LOFRIC HYDRO-KIT FAMILY, DESCRIBING A SIMILAR EVENT. AT THIS POINT, THE MANUFACTURER THEREFORE CONSIDER THIS TO BE AN EXCEPTIONAL, ISOLATED CASE, AND CANNOT FIND ANY POSSIBLE EXPLANATION FOR THE DEFECT CATHETERS. SHOULD ADDITIONAL FACTS PROMPT US TO ALTER OR SUPPLEMENT ANY INFORMATION OF CONCLUSIONS CONTAINED IN THE ORIGINAL MDR OR IN ANY PRIOR SUPPLEMENTAL REPORTS, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED PROBLEMS WHILE PERFORMING INTERMITTENT CATHETERIZATION. THE PATIENT REPORTS THAT SHE HAS EXPERIENCED PAIN, HIGH TEMPERATURE AND URINARY TRACT INFECTIONS. THE PATIENT WENT TO HOSPITAL AND A CYTOSCOPY WAS PERFORMED WHERE BROKEN URINARY CATHETER TIPS WERE DISCOVERED AND SUBSEQUENTLY REMOVED FROM THE BLADDER. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL THE SAME DAY, GIVEN A LOW DOSE OF ANTIBIOTICS FOR PROPHYLAXIS TO USE FOR 5-6 MONTHS AND ALSO REPORTS TAKING PAIN MEDICATION AFTER THE CYTOSCOPY. THE PATIENT REPORTS THAT SHE SINCE THE DISCHARGE SHE IS USING FOLEY CATHETERS, AND ACCORDING TO THE DOCTOR´S ADVICE SHE CAN PERFORM INTERMITTENT CATHETERIZATION OR USE THE FOLEY CATHETER AS AN INDWELLING CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    900645 LOFRIC HYDRO-KIT CATHETER, URETHRAL EZD WELLSPECT HEALTHCARE, A DIVISION OF DENTSPLY IH AB 42312 449548 07392532142673

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other| R