BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONVEEN OPTIMA

    MDR report key: 2498838 · Received March 21, 2012

    Report

    Report Number
    3006606901-2012-00007
    Event Type
    Injury
    Date Received
    March 21, 2012
    Report Date
    February 21, 2012
    Manufacturer
    COLOPLAST A/S
    Product Code
    EXJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    TWO PRODUCTS WERE RETURNED FOR EVALUATION. A PEEL TEST WAS PERFORMED ON THE DEVICE AND WAS WITHIN THE SPECIFICATION. THE USER STATED THAT THE INJURY OCCURRED DUE TO USING A PRODUCT THAT WAS TOO SMALL. SEEING THAT THE RETURNED PRODUCT PERFORMED ACCORDING TO DEVICE SPECIFICATIONS IT WAS CONCLUDED THAT HUMAN ERROR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    DATE OF EVENT: BEST ESTIMATE (B)(6) 2012. ACCORDING TO THE INFORMATION RECEIVED, A USER DEVELOPED A BLEEDING SKIN WOUND AFTER USING A URISHEATH. THE USER STATED THAT THE WOUND WAS CAUSED BY USING A SHEATH SIZE THAT WAS TOO SMALL. 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 MALE EXTERNAL CATHETER-UROSHEATH EXJ COLOPLAST A/S 2203001001 3082921

    Patients

    Seq Age Sex Outcome Treatment
    1 Other