BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DERMABOND ADVANCED

    MDR report key: 3003912 · Received March 14, 2013

    Report

    Report Number
    2210968-2013-02458
    Event Type
    Malfunction
    Date Received
    March 14, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 19, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    MPN
    PMA / PMN Number
    P960052
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - SHARD PENETRATION OCCURRED. 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 PACEMAKER SURGERY ON (B)(6) 2013 AND A TOPICAL SKIN ADHESIVE WAS USED. WHILE TRYING TO DISPENSE THE PRODUCT, THE VIAL CRUSHED AND A SMALL SHARD OF GLASS CAME OUT OF THE PIN THROUGH THE TIP. A LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107409 DERMABOND ADVANCED TOPICAL SKIN ADHESIVE MPN ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1