BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONVEEN OPTIMA

    MDR report key: 2420246 · Received January 18, 2012

    Report

    Report Number
    3006606901-2012-00003
    Event Type
    Injury
    Date Received
    January 18, 2012
    Report Date
    December 20, 2011
    Manufacturer
    COLOPLAST A/S
    Product Code
    EXJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 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 SKIN REACTION WAS REPORTED. USER REPORTED STRONG ADHESIVE THE CAUSED SKIN BLOATING AND THE SKIN TO COME OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONVEEN OPTIMA MALE EXTERNAL CATHETER-UROSHEATH EXJ COLOPLAST A/S 2203001004 2892295

    Patients

    Seq Age Sex Outcome Treatment
    1 Other