BEUDAMED
    FDA Adverse Event Summary report: N

    3M IOBAN ANTIMICROBIAL INCISE DRAPE

    MDR report key: 2010260 · Received February 25, 2011

    Report

    Report Number
    2010260
    Date Received
    February 25, 2011
    Date of Event
    February 14, 2011
    Report Date
    February 25, 2011
    Manufacturer
    3M COMPANY
    Product Code
    KKX
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE REMOVING THE IOBAN SURGICAL DRAPE PATIENT SUFFERED A VERY SUPERFICIAL SKIN TEAR OF THE BACK 1.2X2.5CM. MD PREPPED WITH CHLORAPREP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3M IOBAN ANTIMICROBIAL INCISE DRAPE 3M IOBAN SURGICAL DRAPE KKX 3M COMPANY * 2012-11AK

    Patients

    Seq Age Sex Outcome Treatment
    1 5 MO