BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DERMABOND ADVANCED 0.7ML - 12EA

    MDR report key: 15564886 · Received October 7, 2022

    Report

    Report Number
    2210968-2022-08262
    Event Type
    Injury
    Date Received
    October 7, 2022
    Date of Event
    August 25, 2022
    Report Date
    October 7, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    MPN
    UDI-DI
    10705031203532
    PMA / PMN Number
    K152096
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). (B)(4). AS NO CONTACT INFORMATION HAS BEEN PROVIDED, NO FOLLOW UP CAN OR WILL BE PERFORMED AT THIS TIME. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. THIS MEDWATCH REPORT IS IN RESPONSE TO RECEIPT OF A VOLUNTARY MEDWATCH #5111863. NO PRODUCT IS AVAILABLE FOR RETURN. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    PER USER FACILITY MEDWATCH FORM #5111863 IT WAS REPORTED A PATIENT UNDERWENT A LAPAROSCOPIC APPENDECTOMY FOR UNCOMPLICATED APPENDICITIS IN 2022. THE PATIENT'S SKIN WAS PREPPED WITH CHLORAPREP AND HER WOUNDS WERE DRESSED WITH TOPICAL SKIN ADHESIVE FOLLOWING THE SURGERY. SHE DEVELOPED A CONTACT DERMATITIS IN THE AREA AROUND HER UMBILICAL INCISION AND WAS PRESCRIBED HYDROCORTISONE CREAM FOR THE SAME. THE RASH RESOLVED, BUT HER UMBILICAL SKIN AND THE SKIN UNDERLYING THE 5MM INCISIONS IN HER LOW MIDLINE AND LEFT LOWER QUADRANT BECAME HYPERPIGMENTED WITHOUT SIGNS OF INFECTION. THE HYPERPIGMENTATION APPEARS TO BE A SUPERFICIAL BURN. THIS HAS BEEN MANAGED WITH LOCAL WOUND CARE AND ANTIBIOTIC OINTMENT. THE DEVICE IS NOT AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2888964 DERMABOND ADVANCED 0.7ML - 12EA ADHESIVE, TOPICAL SKIN MPN ETHICON INC. DNX12 10705031203532

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Female Required Intervention