BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DERMABOND TOPICAL SKIN ADHESIVE

    MDR report key: 5207645 · Received November 6, 2015

    Report

    Report Number
    2210968-2015-17775
    Event Type
    Injury
    Date Received
    November 6, 2015
    Date of Event
    October 14, 2015
    Report Date
    October 15, 2015
    Manufacturer
    ETHICON INC.
    Product Code
    MPN
    PMA / PMN Number
    K100423
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT TO THE FDA: 11/06/2015. (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 THE PATIENT UNDERWENT MOLE REMOVAL ON (B)(6) 2015 AND TOPICAL SKIN ADHESIVE WAS USED. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED SKIN REACTION, SWELLING, REDNESS AND PAIN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738682 DERMABOND TOPICAL SKIN ADHESIVE ADHESIVE, TOPICAL SKIN MPN ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention