BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLAKE DRAIN UNKNOWN PRODUCT

    MDR report key: 13206984 · Received January 10, 2022

    Report

    Report Number
    2210968-2022-00210
    Event Type
    Injury
    Date Received
    January 10, 2022
    Date of Event
    August 15, 2021
    Report Date
    January 10, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GBX
    PMA / PMN Number
    CL I EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NOT RECEIVED TO DATE. 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: BLAKE DRAINS CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS (REINFECTION POSTGRAFTING, SEPTICEMIA, BLOOD TRANSFUSION) DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS: BLAKE DRAINS, USED IN THESE PROCEDURES? 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: CITATION CITE: J CARD SURG. 2021;36:4083¿4089. DOI: 10.1111/JOCS.15955. 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: EARLY TO MIDTERM SURVIVAL OF PATIENTS WITH DEEP STERNAL WOUND INFECTION MANAGED WITH LAPAROSCOPICALLY HARVESTED OMENTUM. THE OBJECTIVE OF THIS STUDY WAS TO EVALUATE OUTCOMES OF PATIENTS WITH DSWI MANAGED WITH TRANSPOSITION OF LAPAROSCOPICALLY HARVESTED OMENTUM (LHO). BETWEEN 2000 AND 2020, A TOTAL OF 38,623 ADULT PATIENTS WHO UNDERWENT FULL MEDIAN STERNOTOMY FOR CARDIAC SURGERY WERE ANALYZED RETROSPECTIVELY AT OUR INSTITUTION. DSWI OCCURRED IN 455 (1.2%), OF WHOM 364 (93.2%) WERE MANAGED WITH PECTORALIS MYOCUTANEOUS FLAP (PMF) AND 33 (7.2%) WITH LHO. ULTRASOUND SCISSORS WITH BIPOLAR COAGULATION (ETHICON, ENDO-SURGERY INC.) WERE USED. IN ALL PATIENTS, TWO SILASTIC DRAINS (BLAKE DRAIN; ETHICON, INC., A JOHNSON & JOHNSON COMPANY) WERE PLACED IN THE SUBCUTANEOUS AND PECTORALIS DISSECTION PLANES. REPORTED COMPLICATIONS INCLUDED REINFECTION POSTGRAFTING WITH LAPAROSCOPICALLY HARVESTED OMENTUM (LHO) (N=1), SEPTICEMIA (N=5). IN CONCLUSION USE OF LHO IS A SAFE AND VIABLE ALTERNATIVE TO TRADITIONAL MYOCUTANEOUS FLAPS TO MANAGE COMPLEX DSWI. EARLY AND LATE SURVIVAL WERE FAVORABLE IN THIS HIGHRISK POPULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1356815 BLAKE DRAIN UNKNOWN PRODUCT CATHETER, IRRIGATION GBX ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention