BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DERMABOND 2

    MDR report key: 2132788 · Received June 17, 2011

    Report

    Report Number
    2210968-2011-00790
    Event Type
    Injury
    Date Received
    June 17, 2011
    Report Date
    May 26, 2011
    Manufacturer
    ETHICON
    Product Code
    MPN
    PMA / PMN Number
    P960052
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 THORACOTOMY ON (B)(6) 2011 AND TOPICAL SKIN ADHESIVE WAS USED. DURING THE PROCEDURE, THE SURGEON CLOSED WITH SUTURES AND SEALED IT WITH THE SKIN ADHESIVE. THE PATIENT RETURNED TO THE PHYSICIAN ON (B)(6) 2011 WITH CONTACT DERMATITIS AT THE INCISION SITE. MOST OF THE SKIN ADHESIVE HAD SLOUGHED OFF BY THAT TIME. THE PATIENT WAS TREATED WITH A TOPICAL STEROID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DERMABOND 2 ADHESIVE, TOPICAL SKIN MPN ETHICON NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention