BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DERMABOND 2

    MDR report key: 2833114 · Received November 15, 2012

    Report

    Report Number
    2210968-2012-07340
    Event Type
    Injury
    Date Received
    November 15, 2012
    Report Date
    October 23, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    MPN
    PMA / PMN Number
    P960052
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    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 CESAREAN SECTION ON (B)(6) 2012 AND TOPICAL SKIN ADHESIVE WAS USED. THE PATIENT RETURNED ON (B)(6) 2012 WITH AN ECOLI INFECTION. THE WOUND WAS DEBRIDED, DRAINED, AND PACKED. THE PATIENT WAS ALSO PLACED ON ANTIBIOTICS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention