BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DERMABOND

    MDR report key: 3963341 · Received July 29, 2014

    Report

    Report Number
    2210968-2014-10226
    Event Type
    Injury
    Date Received
    July 29, 2014
    Report Date
    July 9, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    MPN
    PMA / PMN Number
    K100423
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 VIA JOURNAL ARTICLE THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT ON AN UNKNOWN DATE AND A TOPICAL SKIN ADHESIVE WAS USED. APPROXIMATELY 1 TO 3 WEEKS POST OPERATIVELY, THE PATIENT DEVELOPED A RASH AROUND THE SURGICAL SITE. THE RASH CLEARED WITH TOPICAL STEROIDS WITHIN 2 WEEKS AND DID NOT RECUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440914 DERMABOND TOPICAL SKIN ADHESIVE MPN ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention