BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEVICE, CYSTOMETRIC, HYDRAULIC

    MDR report key: 13968999 · Received March 31, 2022

    Report

    Report Number
    3017448360-2022-00010
    Event Type
    Malfunction
    Date Received
    March 31, 2022
    Date of Event
    March 1, 2022
    Report Date
    March 31, 2022
    Manufacturer
    LABORIE MEDICAL TECHNOLOGIES
    Product Code
    FEN
    PMA / PMN Number
    K951805
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THE EVENT INVOLVED A TDOC CATHETER, MODEL NUMBER CAT878, USED FOR A URODYNAMIC STUDY. DURING THE STUDY THE PATIENT NOTIFIED THE PROVIDER THAT THE CATHETER WAS UNCOMFORTABLE, AND THE CATHETER WAS REMOVED. THE PATIENT EXPERIENCED BLEEDING WHICH WAS CONTROLLED WITH GAUZE AND PRESSURE APPLICATION. UPON EXAMINATION OF THE CATHETER USED, THE SENSOR WIRE WITHIN THE CATHETER HAD DISLODGED FROM THE END OF THE CATHETER LIKELY CAUSING AN ABRASION OF THE URETERAL MUCOSA. THE PATIENT HAS URINARY RETENTION REQUIRING INTERMITTENT CATHERIZATION AND AN INDWELLING CATHETER HAD TO BE PLACED AT THE TIME TO AVOID FURTHER IRRITATION OF LIKELY ABRASION CAUSED BY THE CATHETER. THIS INCIDENT DID NOT RESULT IN A SERIOUS INJURY OF THE PATIENT. THE EVENT IS BEING REPORTED AS IF THIS INCIDENT WAS TO OCCUR AGAIN MAY REQUIRE MEDICAL INTERVENTION TO PREVENT SERIOUS INJURY OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1186053 DEVICE, CYSTOMETRIC, HYDRAULIC FEN LABORIE MEDICAL TECHNOLOGIES CAT, TDOC, 1X SENS., COU. TIP, 7 FR 7FSC 214195

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown