BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DERMABOND UNKNOWN PRODUCT

    MDR report key: 19487879 · Received June 7, 2024

    Report

    Report Number
    2210968-2024-05730
    Event Type
    Injury
    Date Received
    June 7, 2024
    Date of Event
    May 1, 2024
    Report Date
    June 7, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    MPN
    PMA / PMN Number
    K100423
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). ADDITIONAL INFORMATION: H6 COMPONENT CODE: G07002 - DEVICE NOT RETURNED 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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. NO PRODUCT AVAILABLE FOR RETURN. CITATIONS : PLASTIC & RECONSTRUCTIVE SURGERY-GLOBAL OPEN 12(S5):PAGE 71-72 JOURNAL ARTICLE ATTACHED. 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

    TITLE : DERMABOND FOR REDUCTION MAMMOPLASTY REVISITED: ITS EFFECTS ON POSTOPERATIVE WOUND HEALING THE AIM OF THIS STUDY WAS TO PRESENT AN UPDATED REVIEW OF DERMABOND¿S SAFETY AND EFFICACY IN REDUCTION MAMMOPLASTY PATIENTS. A RETROSPECTIVE ANALYSIS WAS CONDUCTED ON 550 PATIENTS WHO UNDERWENT REDUCTION MAMMOPLASTY BY A SINGLE SURGEON BETWEEN MARCH 2015 AND FEBRUARY 2023. PATIENTS WERE SEPARATED INTO DERMABOND AND NON-DERMABOND DRESSING GROUPS. OUT OF 550 PATIENTS, 278 (50.5%) HAD DERMABOND USED AND 272 (49.5%) DID NOT. WOUND DRESSING FOLLOWING REDUCTION MAMMOPLASTY CAN BE CONDUCTED USING SURFACE 2-OCTYL CYANOACRYLATE (DERMABOND; ETHICON, INC., SOMERVILLE, N.J). THE REPORTED COMPLICATIONS INCLUDED SEROMAS (N=?), DEHISCENCE (N=?), AND HYPERTROPHIC SCARRING (N=?). IN CONCLUSION, DERMABOND¿S USE AS WOUND DRESSING AFTER REDUCTION MAMMOPLASTY WAS ASSOCIATED WITH HIGHER RATES OF SEROMAS, DEHISCENCE, AND SCARRING SUGGESTING A NEGATIVE IMPACT ON POSTOPERATIVE OUTCOMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2126044 DERMABOND UNKNOWN PRODUCT ADHESIVE, TOPICAL SKIN MPN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other