BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DERMABOND ADVANCED TOPICAL SKIN ADHESIVE

    MDR report key: 3200979 · Received July 2, 2013

    Report

    Report Number
    1527736-2013-00032
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    June 18, 2013
    Manufacturer
    ETHICON ENDO SURGERY, INC (CINCINNATI)
    Product Code
    MPN
    PMA / PMN Number
    K100423
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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 BREAST BIOPSY ON AN UNKNOWN DATE AND A TOPICAL SKIN ADHESIVE WAS USED. TWO WEEKS FOLLOWING THE PROCEDURE, THE PATIENT DEVELOPED A CELLULITIS AT THE INCISION SITE. THE PATIENT WAS TREATED WITH ANTIBIOTICS. THE CELLULITIS RESOLVED AFTER THE TREATMENT OF ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303533 DERMABOND ADVANCED TOPICAL SKIN ADHESIVE ADHESIVE, TOPICAL SKIN MPN ETHICON ENDO SURGERY, INC (CINCINNATI) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention