BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OUCHLESS ADHESIVE PAD

    MDR report key: 2312504 · Received October 5, 2011

    Report

    Report Number
    1018120-2011-00020
    Event Type
    Malfunction
    Date Received
    October 5, 2011
    Report Date
    September 21, 2011
    Manufacturer
    COVIDIEN
    Product Code
    GEL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2011 THAT A CUSTOMER HAD AN ISSUE WITH A PACKING STRIP. THE CUSTOMER REPORTED THE PACKING STRIP WAS USED FOR PACKING A WOUND AND BROKE OFF WHILE IT WAS BEING REMOVED FROM THE PT'S WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OUCHLESS ADHESIVE PAD PACKING STRIP GEL COVIDIEN UNK WC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK