BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRINEO SKIN CLOSURE SYSTEM

    MDR report key: 3003902 · Received March 14, 2013

    Report

    Report Number
    2210968-2013-02424
    Event Type
    Injury
    Date Received
    March 14, 2013
    Report Date
    February 19, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OMD
    PMA / PMN Number
    P960052
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - INFECTION OCCURRED. CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A MASTECTOMY ON (B)(6) 2012 AND TOPICAL SKIN ADHESIVE WAS USED ALONG THE ENTIRE LENGTH OF THE INCISION. IT WAS PLACED OVER THE INCISION THAT WAS FIRST FULLY CLOSED WITH SUTURE. HIBICLENS WAS ALSO USED DURING THE PROCEDURE. THE TOPICAL SKIN ADHESIVE WAS REMOVED ABOUT TWO WEEKS AFTER BEING APPLIED AND THE PATIENT HAD AN INFECTION WITH A STRONG APPEARANCE OF REDNESS AT THE SITE THAT THE TOPICAL SKIN ADHESIVE WAS PLACED. THE PATIENT WAS CULTURED ON (B)(6) 2013. ANTIBIOTICS WERE RECOMMENDED. THE PATIENT IS DOING FINE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107690 PRINEO SKIN CLOSURE SYSTEM SURGICAL SEALANT OMD ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention