BEUDAMED
    FDA Adverse Event Death Summary report: N

    DERMABOND UNKNOWN PRODUCT

    MDR report key: 18617749 · Received January 31, 2024

    Report

    Report Number
    2210968-2024-00844
    Event Type
    Death
    Date Received
    January 31, 2024
    Date of Event
    December 5, 2022
    Report Date
    February 9, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    MPN
    PMA / PMN Number
    K100423
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). ADDITIONAL INFORMATION: H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE: DEATH, DEEP SPACE INFECTION? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? PATIENT DEMOGRAPHICS? ARE THE CAUSES OF DEATH AND AUTOPSIES AVAILABLE FOR THE PATIENTS WHO EXPIRED? THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: DOI: 10.7759/CUREUS.32228. RELATED EVENTS CAPTURED VIA: MW# 2210968-2024-00841, MW# 2210968-2024-00842, MW# 2210968-2024-00843, MW# 2210968-2024-00845, MW# 2210968-2024-00846. 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 INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, 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

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: ROLE OF PROPHYLACTIC SARTORIUS FLAPS FOR PREVENTING DEEP SPACE INFECTION IN LOWER EXTREMITY REVASCULARIZATION AUTHORS: BRANDON LARSON, JOSEPH DIBELLO III, LOGAN ERZ , DAVID GOTHARD , ERIC TURNEY CITATION: DOI: 10.7759/CUREUS.32228. THE STUDY AIMED TO COMPARE PROPHYLACTIC SARTORIUS FLAPS TO LAYERED CLOSURE IN PREVENTING READMISSION FOR DSI, ALONG WITH THE EFFECT OF INCISION ORIENTATION. THIS WAS A RETROSPECTIVE STUDY OF VASCULAR SURGERY PATIENTS AT A SINGLE INSTITUTION WITH FEMORAL ARTERY EXPOSURE FROM 2017-2021. FIFTY-THREE PATIENTS RECEIVED SARTORIUS FLAPS, AND 122 RECEIVED LAYERED CLOSURE. SEVENTY PATIENTS HAD OBLIQUE INCISIONS, AND 105 PATIENTS HAD VERTICAL INCISIONS. LAYERED CLOSURE INVOLVED THREE LAYERS, INCLUDING TOPICAL HEMOSTATIC AGENTS FOLLOWED BY A RUNNING 2-0 VICRYL FOR (ETHICON) THE FEMORAL SHEATH, A 4-0 MONOCRYL (ETHICON) SUBCUTICULAR LAYER, AND SKIN COVERED WITH DERMABOND (ETHICON). THE REPORTED COMPLICATIONS (N=52) DEATH AND (N=18) DEEP SPACE INFECTION, TREATMENT: ANTIBIOTICS. IN CONCLUSION, PATIENTS UNDERGOING LOWER EXTREMITY REVASCULARIZATION PROCEDURES INVOLVING GROIN INCISIONS ARE AT HIGH RISK FOR WOUND COMPLICATIONS, WITH DEEP SPACE INFECTION BEING THE MOST CONCERNING FOR POTENTIAL LIMB LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1260110 DERMABOND UNKNOWN PRODUCT ADHESIVE, TOPICAL SKIN MPN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death