BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DERMABOND

    MDR report key: 3964771 · Received July 29, 2014

    Report

    Report Number
    2210968-2014-10275
    Event Type
    Injury
    Date Received
    July 29, 2014
    Date of Event
    July 6, 2014
    Report Date
    July 8, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    MPN
    PMA / PMN Number
    K100423
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 BY THE PATIENT THAT SHE UNDERWENT BREAST AUGMENTATION SURGERY AND A TOPICAL SKIN ADHESIVE WAS USED. APPROXIMATELY 2 WEEKS POST OPERATIVE, THE PATIENT DEVELOPED A HIVE LIKE RASH. SHE WAS TREATED WITH A STEROID INJECTION AND AN ORAL STEROID. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441576 DERMABOND TOPICAL SKIN ADHESIVE MPN ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention