BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DERMABOND 2

    MDR report key: 2485800 · Received March 9, 2012

    Report

    Report Number
    2210968-2012-00585
    Event Type
    Injury
    Date Received
    March 9, 2012
    Report Date
    February 17, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    KOG
    PMA / PMN Number
    P960052
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    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 THAT A PATIENT HAD A MEDIPORT INSERTION ON (B)(6) 2012 AND TOPICAL SKIN ADHESIVE WAS USED ON THE WOUND SITE. THE PATIENT HAD ITCHING AND A RASH WITH NO DRAINAGE OR INFECTIONS AT THE INCISION SITE. THE PHYSICIAN ORDERED BENADRYL FOR THE PATIENT BUT DID NOT REMOVE THE TOPICAL SKIN ADHESIVE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention