BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DERMABOND ADVANCED TOPICAL SKIN ADHESIVE

    MDR report key: 3893783 · Received June 25, 2014

    Report

    Report Number
    2210968-2014-08167
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 5, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    MPN
    PMA / PMN Number
    K100423
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    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 TOTAL KNEE REPLACEMENT ON (B)(6) 2014 AND TOPICAL SKIN ADHESIVE WAS USED. THE PATIENT RETURNED TO THE SURGEON THREE WEEKS LATER AND REPORTED THAT SHE HAD A SKIN REACTION. THE PATIENT HAD SEEN A GENERAL PRACTITIONER WHO DESCRIBED IT AS A MACULAR PAPULAR RASH OVER THE ENTIRE LOWER LEG. THE CURRENT CONDITION OF THE PATIENT'S RASH WAS REPORTED AS BEING CLEARED UP. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370795 DERMABOND ADVANCED TOPICAL SKIN ADHESIVE ADHESIVE, TOPICAL SKIN MPN ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention