BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DERMABOND TOPICAL SKIN ADHESIVE

    MDR report key: 3782145 · Received April 30, 2014

    Report

    Report Number
    2210968-2014-05481
    Event Type
    Injury
    Date Received
    April 30, 2014
    Report Date
    April 10, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    MPN
    PMA / PMN Number
    K100423
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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 LAPAROSCOPIC NISSEN FUNDOPLICATION PROCEDURE ON (B)(6) 2014 AND TOPICAL SKIN ADHESIVE WAS USED. THREE DAYS POST-OPERATIVELY, THE PATIENT DEVELOPED A SEVERE SKIN REACTION. THERE WAS A RED, RAISED AREA AROUND EACH OF THE 5 PORT SITES THAT PROGRESSED TO THE ABDOMEN. THE PATIENT WAS GIVEN A MEDROL DOSE PACK. THE REACTION HAS CLEARED UP, BUT THE PATIENT HAS OCCASIONAL FLARE UPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260050 DERMABOND TOPICAL SKIN ADHESIVE ADHESIVE, TOPICAL SKIN MPN ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention