BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DERMABOND

    MDR report key: 5226756 · Received November 16, 2015

    Report

    Report Number
    2210968-2015-18432
    Event Type
    Injury
    Date Received
    November 16, 2015
    Report Date
    November 3, 2015
    Manufacturer
    ETHICON INC.
    Product Code
    MPN
    PMA / PMN Number
    K100423
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT THYROIDECTOMY ON AN UNKNOWN DATE. THE TOPICAL SKIN ADHESIVE WAS USED ON THE SKIN IN TWO LAYERS. APPROXIMATELY 24 HOURS AFTER THE PROCEDURE, THE PATIENT EXPERIENCED ALLERGIC DERMATITIS WITH BULLAE, RED AND ITCHY LIMITED TO THE APPLICATION OF THE TOPICAL SKIN ADHESIVE. THE TOPICAL SKIN ADHESIVE WAS REMOVED, CORTISONE LOTION APPLIED AND PATIENT WAS PRESCRIBED BENADRYL AND MEDROL DOSEPACK. THE SITE WAS CULTURED AND NO BACTERIA WAS FOUND. THE PATIENT RECOVERED IN LESS THAN ONE WEEK.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: TO DATE, THE DEVICE HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED FOR EVALUATION, ANY FURTHER INFO DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND TOPICAL SKIN ADHESIVE WAS USED. THE PATIENT EXPERIENCED AN ALLERGIC DERMATITIS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755878 DERMABOND ADHESVIE, TOPICAL MPN ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention