BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EQUOS BORDERED GAUZE 4X114

    MDR report key: 2466041 · Received February 9, 2012

    Report

    Report Number
    3006475494-2012-00006
    Event Type
    Malfunction
    Date Received
    February 9, 2012
    Date of Event
    November 1, 2011
    Report Date
    November 14, 2011
    Manufacturer
    BRADY TECHNOLOGY WUXI CO. LTD.
    Product Code
    FQM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    BANDAGES DID NOT ADHERE TO THE PTS AS WELL AS THEY HAD PREVIOUSLY AND THE ADHESIVES ON THE BANDAGES GAVE PTS SKIN BLISTERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EQUOS BORDERED GAUZE 4X114 BORDERED GAUZE BANDAGE 4X14 FQM BRADY TECHNOLOGY WUXI CO. LTD. 19867241

    Patients

    Seq Age Sex Outcome Treatment
    1