BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPEEDICATH CH14 MALE

    MDR report key: 2200163 · Received August 10, 2011

    Report

    Report Number
    3006606901-2011-00025
    Event Type
    Injury
    Date Received
    August 10, 2011
    Report Date
    July 12, 2011
    Manufacturer
    COLOPLAST A/S
    Product Code
    GBM
    PMA / PMN Number
    K023254
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS BEEN REQUESTED BUT AS OF TO DATE NO PRODUCT WAS AVAILABLE FOR TESTING. WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURENCE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED. FOLLOW UP 1- 3 CATHETERS WERE RETURNED FOR EVALUATION. IT WAS DETERMINED THAT THE CATHETERS WERE DRAINING AND THE EYELETS WERE WITHOUT FAULT. HOWEVER, IT WAS FOUND THAT THE CATHETERS WERE FOLDED AND THE MATERIAL OF THE PRODUCT WAS BROKEN WHICH CAN CAUSE THE CATHETER NOT TO DRAIN. THE CUSTOMER WAS ADVISED NOT TO FOLD THE CATHETER.

    Additional Manufacturer Narrative · 1

    PRODUCT HAS BEEN REQUESTED BUT AS OF TO DATE NO PRODUCT WAS AVAILABLE FOR TESTING. WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURRENCE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    (B)(4).ACCORDING TO THE INFORMATION RECEIVED, A USER REPORTED THAT A CATHETER WAS NOT DRAINING.

    Description of Event or Problem · 1

    (B)(4).ACCORDING TO THE INFORMATION RECEIVED, A USER REPORTED THAT A CATHETER WAS NOT DRAINING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPEEDICATH CH14 MALE INTERMITTENT CATHETER GBM COLOPLAST A/S 2841401006 2778833

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention