BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURE CATHETER

    MDR report key: 6888503 · Received September 22, 2017

    Report

    Report Number
    3005471919-2017-00002
    Event Type
    Malfunction
    Date Received
    September 22, 2017
    Date of Event
    August 23, 2017
    Report Date
    September 22, 2017
    Manufacturer
    CURE MEDICAL LLC
    Product Code
    EZD
    UDI-DI
    00815947020031
    PMA / PMN Number
    K072539
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    USER RETURNED AN INCOMPLETE USED DEVICE. EVALUATION OF RETURNED INCOMPLETE DEVICE CONFIRMED A SHARP POINT AT THE TIP OF THE DEVICE. THE ORIGINAL CATHETER TIP WAS NOT RETURNED, NOR WAS THE ORIGINAL DEVICE PACKAGING. USER STATED HE DID NOT EXAMINE CATHETER OR PACKAGING BEFORE USE AND DOES NOT HAVE THE PACKAGING OR TIP IN HIS POSSESSION. SINCE AN INCOMPLETE DEVICE WAS RETURNED AND THE USER IS UNABLE TO PROVIDE DETAILS OF THE CONDITION OF THE DEVICE PRIOR TO USE, ONLY A PARTIAL DEVICE EVALUATION IS POSSIBLE. THE PARTIAL DEVICE EVALUATION IS INSUFFICIENT TO DETERMINE THE ROOT CAUSE OF THE DEFECT.

    Description of Event or Problem · 1

    USER EXPERIENCED BLEEDING AND PAIN DURING INSERTION OF INTERMITTENT URINARY CATHETER. UPON REMOVAL OF CATHETER AND EXAMINATION, USER OBSERVED THE CATHETER TIP SEEMED MORE POINTED THAN USUAL. NO MEDICAL ATTENTION WAS REQUIRED AND USER HAS FULLY RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666238 CURE CATHETER URINARY CATHETER EZD CURE MEDICAL LLC M14 170114-1 00815947020031

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other