BEUDAMED
    FDA Adverse Event Death Summary report: N

    BLAKE DRAIN UNKNOWN PRODUCT

    MDR report key: 19832739 · Received July 25, 2024

    Report

    Report Number
    2210968-2024-07667
    Event Type
    Death
    Date Received
    July 25, 2024
    Date of Event
    September 12, 2023
    Report Date
    July 25, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GBX
    PMA / PMN Number
    CL I EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). ADDITIONAL INFORMATION: H6 COMPONENT CODE: G07002 - DEVICE NOT RETURNED. ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NOT RECEIVED. 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 ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF DETERMINED, WHAT WAS THE CAUSE OF DEATH? THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. NO PRODUCT AVAILABLE FOR RETURN. CITATIONS : SURGICAL INFECTIONS. VOLUME 23, NUMBER 8, PAGES : 1-7 . DOI: 10.1089/SUR.2022.175 JOURNAL ARTICLE ATTACHED. AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. 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 : CLINICAL IMPACT OF TWO-WEEK PLACEMENT OF A SUBCUTANEOUS SUCTION DRAIN IN PREVENTING INCISIONAL SURGICAL SITE INFECTION IN OPEN GASTROINTESTINAL SURGERY WITH CLASS 4 DIRTY WOUND: A RETROSPECTIVE STUDY. THIS STUDY AIMED TO EVALUATE THE EFFICACY OF SUBCUTANEOUS SUCTION DRAINS (SSDS) COMPARED WITH PRIMARY SKIN CLOSURE (PC) IN CLASS 4 DIRTY WOUND SURGERY. BETWEEN 2015 TO 2021, EIGHTY-ONE PATIENTS UNDERGOING OPEN GASTROINTESTINAL SURGERY WITH CLASS 4 DIRTY WOUNDS WERE ENROLLED IN THIS STUDY, 30 OF WHOM UNDERWENT SSD INSERTION, WHEREAS THE OTHER 51 WERE TREATED WITH PC. THE MEDIAN AGE OF THE PATIENTS WAS 76 (RANGE, 30¿93) YEARS, AND 42 (51.8%) WERE MALES. PRIMARY SKIN CLOSURE WAS DEFINED AS CLOSURE OF THE ABDOMINAL FASCIA AND SKIN AT THE END OF SURGERY. AN INTERRUPTED SUTURE USING 0-PDS WAS PERFORMED TO CLOSE THE FASCIA LAYER. IN CASES WITH SSD INSERTION, 15-FR BLAKE SILICON DRAINS (ETHICON, SOMERVILLE, NJ) WERE USED AS THE DRAINAGE TUBE AND PLACED ALONG WITH INCISIONAL WOUNDS. THE DRAIN WAS CONNECTED TO J-VACTM RESERVOIRS (ETHICON), WHICH OFFERED LOW CONTINUOUS PRESSURE TO ENABLE THE FULL LENGTH OF THE INCISION TO BE DRAINED. THE REPORTED COMPLICATIONS INCLUDED MORTALITY (N=3), WOUND COMPLICATION : INCISIONAL SURGICAL SITE INFECTION (N=14), WOUND SEPARATION (N=6) , CULTURE CONFIRMATION OF INCISIONAL SSI (N=11) AND COMPLICATIONS CLAVIEN -DINDO GRADE =3 (N=19). IN CONCLUSION, THIS STUDY SUGGESTED THE POTENTIAL IMPORTANCE OF A TWO-WEEK PLACEMENT OF AN SSD FOR PREVENTING INCISIONAL SSI IN CLASS 4 DIRTY WOUND SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187026 BLAKE DRAIN UNKNOWN PRODUCT CATHETER, IRRIGATION GBX ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death