BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DERMABOND TOPICAL SKIN ADHESIVE

    MDR report key: 2042609 · Received April 6, 2011

    Report

    Report Number
    2210968-2011-00391
    Event Type
    Injury
    Date Received
    April 6, 2011
    Report Date
    March 10, 2011
    Manufacturer
    NI
    Product Code
    MPN
    PMA / PMN Number
    P960052
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 04/06/2011. (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 OOPHORECTOMY PROCEDURE ON (B)(6) 2010 AND TOPICAL SKIN ADHESIVE WAS USED. TWO TO THREE WEEKS AFTER THE PROCEDURE, THE PATIENT EXPERIENCED A FOREIGN BODY REACTION. THE PATIENT WAS UNDER THE CARE OF A DERMATOLOGIST FOR FIVE MONTHS. THE PATIENT WAS TREATED WITH STEROID INJECTIONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention