BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURE CATHETER

    MDR report key: 4425711 · Received January 13, 2015

    Report

    Report Number
    3006430057-2015-00002
    Event Type
    Injury
    Date Received
    January 13, 2015
    Date of Event
    August 29, 2014
    Report Date
    January 7, 2015
    Manufacturer
    INTEGRAL MEDICAL PRODUCTS CO. LTD.
    Product Code
    EZD
    PMA / PMN Number
    K072539
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE NAMED IN THE VOLUNTARY REPORT IS A DEVICE PRODUCED AT OUR FACILITY AS A CONTRACT MANUFACTURER. HOWEVER, THE DETAILS PROVIDED MAKE US BELIEVE THE CATHETER USED IS NOT A DEVICE WHICH WE CONTRACT MANUFACTURE. THE DETAILS ABOUT THE DEVICE DO NOT INDICATE A SELF-INTERMITTENT CATHETER. ALSO, THIS INDIVIDUAL DOES NOT HAVE A PRESCRIPTION FOR SELF-INTERMITTENT CATHETERS, AND NO DEVICE WAS RETURNED TO US OR TO THE SPECIFICATION DEVELOPER FOR EVALUATION. WE HAVE NO RESULTS TO REPORT OTHER THAN THE DETAILS PROVIDED DO NOT INDICATE ANY PRODUCT THAT WE MANUFACTURE/PRODUCE. THE SPECIFICATION DEVELOPER MADE CONTACT WITH THE INDIVIDUAL REPORTING VOLUNTARILY TO FDA AND THIS PERSON HAS NOT RESPONDED TO REQUESTS FOR ADDITIONAL INFORMATION AND HAS NOT PROVIDED DOCUMENTATION TO SUPPORT THE CLAIM THAT THE PRODUCT IS ONE THAT WE CONTRACT MANUFACTURE AT OUR ESTABLISHMENT. WE DO NOT KNOW OF ANY PROBLEMS WITH OUR DEVICES AND WE HAVE NO EVIDENCE TO INDICATE WE ARE REQUIRED TO REPORT THIS EVENT UNDER FDA REGULATION. HOWEVER, WE FILE OUR REPORT IN RESPONSE TO THE TWO REPORTS THAT HAVE BEEN FILED: ONE REPORT BY THE SPECIFICATION DEVELOPER AND THE OTHER BEING THE VOLUNTARY REPORT.

    Description of Event or Problem · 1

    DURING RESEARCH AND POST-MARKET SURVEILLANCE, WE FOUND THE FOLLOWING VOLUNTARY REPORT FILED WITH FDA. WE DISCUSSED WITH THE SPECIFICATION DEVELOPER AND THEY ALSO FILED A MDR REPORT. AN INDIVIDUAL FILED A VOLUNTARY MEDWATCH REPORT AND SAID THE DEVICE CAUSING THEIR PROBLEM WAS ONE THAT WE CONTRACT MANUFACTURE FOR A USA SPECIFICATION DEVELOPER. THIS INDIVIDUAL WROTE HE HAD PAIN AND INDICATED HEMATURIA WHILE BEING CATHETERIZED WITH A 16 FR CATHETER AT AN EMERGENCY ROOM. HE REQUESTED TO HAVE THE 16 FR CATHETER REMOVED, BUT THE E.R. PERSONNEL WOULD NOT REMOVE IT UNTIL AFTER A UROLOGIST EXAMINED HIM. THE INDIVIDUAL WAS UNHAPPY AND LEFT THIS E.R. WITH THE CATHETER STILL INSIDE HIM. HE WENT TO A DIFFERENT EMERGENCY ROOM AND THE PERSONNEL AT THIS SECOND E.R. REMOVED THE CATHETER. HE SAID HE READ IN A "HOSPITAL REPORT" THAT THE CATHETER WAS A 16 FR STRAIGHT INTERMITTENT CATHETER AND WAS A BRAND NAME THAT WE CONTRACT MANUFACTURE AT OUR FACILITY. DURING TELEPHONE INTERVIEWS WITH THE SPECIFICATION CONSULTANT, HE STATED THAT THE PERSONNEL WHO REMOVED THE CATHETER DID "SOMETHING WITH A SYRINGE TO REMOVE IT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31492 CURE CATHETER UROLOGICAL CATHETER EZD INTEGRAL MEDICAL PRODUCTS CO. LTD. M16 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other