BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASICATH CH12 MALE, 25PCS (SURECATH)

    MDR report key: 1525781 · Received November 12, 2009

    Report

    Report Number
    3003814961-2009-00001
    Event Type
    Injury
    Date Received
    November 12, 2009
    Report Date
    October 12, 2009
    Manufacturer
    COLOPLAST A/S
    Product Code
    EZD
    PMA / PMN Number
    K973070
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE EXACT LOT NUMBER COULD NOT BE DETERMINED, IT WAS NARROWED TO THE FOLLOWING 4 LOTS: 2061344, 1949454, 1600672,1958778. THESE WERE EVALUATED AS FOLLOWS: LOT # 2061344 -- NO ADDITIONAL COMPLAINTS HAVE BEEN RECORDED FOR THIS LOT NUMBER. NO NCR FOR THIS LOT. FINGER TEST ON COATING & FRICTION TESTS CONDUCTED ON RETURNED SAMPLES. RESULTS MET SPECIFICATION. LOT # 1949454 -- NO ADDITIONAL COMPLAINTS HAVE BEEN RECORDED FOR THIS LOT NUMBER. NO NCR FOR THIS LOT. FINGER TEST ON COATING & FRICTION TESTS CONDUCTED ON RETURNED SAMPLES. RESULTS MET SPECIFICATION. LOT # 1600672 -- NO ADDITIONAL COMPLAINTS HAVE BEEN RECORDED FOR THIS LOT NUMBER. NO NCR FOR THIS LOT. FINGER TEST ON COATING & FRICTION TESTS CONDUCTED ON RETURNED SAMPLES. RESULTS MET SPECIFICATION. LOT # 1958778 -- 1 ADDITIONAL COMPLAINT HAS BEEN RECORDED FOR THIS LOT NUMBER FOR "CATHETER - STUCK TO PRIMARY PACKAGING". NO NCR FOR THIS LOT. NO SAMPLES RETURNED FOR ANALYSIS. TESTING OF THE EASICATH CATHETERS RETURNED DID NOT PROVIDE US WITH AN EXPLANATION AS TO THE CAUSE OF THE INCIDENT REPORTED. THE PRODUCTS WERE FOUND IN CONFORMANCE WITH SPECIFICATIONS. A REVIEW OF THE PRODUCT DOCUMENTATION FOR THESE LOT NUMBERS DID NOT REVEAL ANY DEVIATION THAT COULD BE RELATED TO THE COMPLAINT.

    Description of Event or Problem · 1

    DATE OF EVENT: 2009. ACCORDING TO THE INFORMATION RECEIVED, AN END USER REPORTED BLEEDING. THE PATIENT WAS BLEEDING USING THE CATHETER AND CLAIMS THE COATING IS NOT PROPER. FOUR (4) DIFFERENT LOT NUMBERS HAVE BEEN IDENTIFIED, AND SINCE WE DON'T KNOW WHICH ONE MATCHES THIS PRODUCT,

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASICATH CH12 MALE, 25PCS (SURECATH) INTERMITTENT CATHETER EZD COLOPLAST A/S 535201038 2061344, 1949454, 1600672,1958

    Patients

    Seq Age Sex Outcome Treatment
    1