BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DERMABOND TOPICAL SKIN ADHESIVE

    MDR report key: 2010646 · Received February 24, 2011

    Report

    Report Number
    2210968-2011-00204
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    January 21, 2011
    Report Date
    January 25, 2011
    Manufacturer
    ETHICON, INC.
    Product Code
    MPN
    PMA / PMN Number
    P960052
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): CONCLUSIONS: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADD'L INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT A VENOUS PORT-A-CATH INSERTION PROCEDURE AND TOPICAL SKIN ADHESIVE WAS APPLIED. THE PT EXPERIENCED ITCHING ON (B)(6) 2011, THEN RETURNED TO THE CLINIC FOUR DAYS LATER, WHERE THE DERMABOND WAS REMOVED AND STERI STRIPS WERE PUT IN PLACE. THE PT ALSO EXPERIENCED ERYTHEMA WITH SMALL VESICLES IN THE SAME AREA THAT THE TOPICAL SKIN ADHESIVE CONTACTED THE SKIN. THE PT WAS TREATED WITH ORAL DICLOXACILLIN. THE PT IS NOW FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DERMABOND TOPICAL SKIN ADHESIVE ADHESIVE, TOPICAL SKIN MPN ETHICON, INC. NA CLP165

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention