BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONVEEN OPTIMA

    MDR report key: 2822287 · Received May 29, 2012

    Report

    Report Number
    3006606901-2012-00011
    Event Type
    Injury
    Date Received
    May 29, 2012
    Date of Event
    February 1, 2012
    Report Date
    February 9, 2012
    Manufacturer
    COLOPLAST A/S
    Product Code
    EXJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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 COMMENCING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURRENCE. SHOULD ADDITIONAL INFO BECOME AVAILABLE A F/U REPORT WILL BE SUBMITTED. F/U 1: 3 DEVICES WERE RETURNED FOR EVAL. ALL OF THE MEASURED VALUES WERE WITHIN SPECIFICATION. BASED UPON THE PERFORMANCE TESTING, THIS COMPLAINT CANNOT BE CONFIRMED AS REPORTED.

    Description of Event or Problem · 1

    ACCORDING TO THE INFO RECEIVED, A USER REPORTED THAT A MALE EXTERNAL CATHETER GAVE HIM AN INFECTION. THE ADHESIVE WAS SO STRONG, THAT THE REMOVAL PROCESS WAS DIFFICULT AND PEELED OFF HIS SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONVEEN OPTIMA MALE EXTERNAL CATHETER-UROSHEATH EXJ COLOPLAST A/S 2203001400 3063776

    Patients

    Seq Age Sex Outcome Treatment
    1 Other