BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONVEEN OPTIMA 25

    MDR report key: 2822177 · Received April 26, 2012

    Report

    Report Number
    3006606901-2012-00010
    Event Type
    Injury
    Date Received
    April 26, 2012
    Date of Event
    March 16, 2012
    Report Date
    March 29, 2012
    Manufacturer
    COLOPLAST A/S
    Product Code
    EXJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ONE PRODUCT WAS RETURNED FOR EVALUATION. A PEEL TEST WAS PERFORMED ON THE DEVICE AND WAS WITHIN THE SPECIFICATION. SEEING THAT THE RETURNED PRODUCT PERFORMED ACCORDING TO DEVICE SPECIFICATIONS THIS COMPLAINT CANNOT BE CONFIRMED AS REPORTED.

    Description of Event or Problem · 1

    DATE OF EVENT: (B)(6) 2012. ACCORDING TO THE INFORMATION RECEIVED, A USER EXPERIENCED IRRITATION AND BLEEDING SKIN AFTER USING A URISHEATH. THE USER APPLIED CREAM TO THE WOUND TO HELP IT HEAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONVEEN OPTIMA 25 MALE EXTERNAL CATHETER-UROSHEATH EXJ COLOPLAST A/S 2202501001 3069440

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other