BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUACEL AG-HYDROFIBER DRESSING

    MDR report key: 4102216 · Received September 17, 2014

    Report

    Report Number
    1000317571-2014-00083
    Event Type
    Malfunction
    Date Received
    September 17, 2014
    Date of Event
    September 1, 2014
    Report Date
    September 2, 2014
    Manufacturer
    CONVATEC LIMITED
    Product Code
    FRO
    PMA / PMN Number
    K013814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS FURTHER REPORTED THE PRODUCT WAS NOT USED ON A PT. BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. THERE WERE NO REPORTS OF THE PT BEING HARMED AS A RESULT OF THIS MALFUNCTION. A RETURN SAMPLE FOR EVAL IS NOT EXPECTED. NO ADD'L PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADD'L INFO BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. THERE IS AN ADD'L CASE ASSOCIATED WITH THIS PRODUCT; THEREFORE A SEPARATE FDA 3500A FORM HAS BEEN GENERATED TO ADDRESS THE OTHER CASE. REPORTED TO THE FDA ON (B)(4) 2014. (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PRIMARY PACKAGING WAS NOT SEALED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576198 AQUACEL AG-HYDROFIBER DRESSING DRESSING, WOUND, DRUG, 79 FRO FRO CONVATEC LIMITED 403710 4A01139

    Patients

    Seq Age Sex Outcome Treatment
    1