BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONVEEN OPTIMA

    MDR report key: 1903785 · Received November 20, 2010

    Report

    Report Number
    3006606901-2010-00010
    Event Type
    Injury
    Date Received
    November 20, 2010
    Date of Event
    May 19, 2010
    Report Date
    October 29, 2010
    Manufacturer
    COLOPLAST A/S
    Product Code
    EXJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    ATTORNEY

    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.

    Description of Event or Problem · 1

    (B)(4). ACCORDING TO THE INFORMATION RECEIVED, A COMPLAINT WAS FILLED BY A LAWYER WHO IS THE LEGAL GUARDIAN TO A (B)(6) SEVERLY DISABLED MALE PATIENT. THE PATIENT USED CONVEEN OPTIMA AND THE ADHESION WAS INSUFFICIENT. DUE TO THIS HE USED ADDITIONALLY (B)(4), AT THE FIRST APPLICATION WITHOUT ANY PROBLEMS. AT THE 2ND APPLICATION-AT REMOVAL-THE PENILE SHEATH SKIN WAS TEARED OFF AT 4 SITES (EACH WITH 4MM X 10MM) WHICH RESULTED IN SEVERE BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONVEEN OPTIMA MALE EXTERNAL CATHETER-UROSHEATH EXJ COLOPLAST A/S 2203001004

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention