BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DERMABOND

    MDR report key: 3912881 · Received July 3, 2014

    Report

    Report Number
    2210968-2014-08665
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Report Date
    June 17, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    MPN
    PMA / PMN Number
    K100423
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 CARE ON DENUDED SKIN BENEATH AN OSTOMY POUCH AND A TOPICAL SKIN ADHESIVE WAS USED ON AN UNKNOWN DATE. THE PATIENT EXPERIENCED UNSPECIFIED BURNING WHEN THE ADHESIVE WAS APPLIED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390978 DERMABOND TOPICAL SKIN ADHESIVE MPN ETHICON INC. UNK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1