BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DERMABOND TOPICAL SKIN ADHESIVE

    MDR report key: 2111981 · Received June 2, 2011

    Report

    Report Number
    2210968-2011-00712
    Event Type
    Injury
    Date Received
    June 2, 2011
    Report Date
    May 13, 2011
    Manufacturer
    ETHICON
    Product Code
    MPN
    PMA / PMN Number
    P960052
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    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 AND TOPICAL SKIN ADHESIVE WAS USED. (B)(6) POST OP, THE PATIENT EXPERIENCED CELLULITIS OF THE WOUND. THE PATIENT ALSO HAD A SUBCUTICULAR CLOSURE. THE PATIENT WAS STARTED ON ANTIBIOTICS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention