BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLAKE DRAIN UNKNOWN PRODUCT

    MDR report key: 15383982 · Received September 8, 2022

    Report

    Report Number
    2210968-2022-07372
    Event Type
    Injury
    Date Received
    September 8, 2022
    Date of Event
    September 27, 2021
    Report Date
    September 8, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GBX
    PMA / PMN Number
    CL I EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). (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 ANY OF THE ETHICON PRODUCTS INVOLVED: 15 FR BLAKE DRAIN CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS: INFECTION, SEROMA, SKIN NECROSIS, CELLULITIS, DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCT 15 FR BLAKE DRAIN USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WHICH SPECIFIC ETHICON 15 FR BLAKE DRAIN PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? PATIENT DEMOGRAPHICS? 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 CITE: JOURNAL OF PLASTIC, RECONSTRUCTIVE & AESTHETIC SURGERY 75 (2022) 737¿742 HTTPS://DOI.ORG/10.1016/J.BJPS.2021.09.054. 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

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: INTRODUCING MINIMALLY INVASIVE INGUINAL LYMPH NODE DISSECTION IN A UK TERTIARY SKIN CANCER SERVICE: INITIAL EXPERIENCE & OUTCOMES. THE AIM OF THIS STUDY WAS TO DESCRIBE THE OUTCOMES OF SETTING UP AN MILND SERVICE IN A UK CANCER CENTRE INSIDE A PRESCRIBED CLINICAL GOVERNANCE FRAMEWORK. THIS WAS A RETROSPECTIVE, SINGLE-CENTRE, SINGLE-SURGEON COHORT STUDY. TWENTY-ONE PATIENTS WHO UNDERWENT MILND FROM MAY 2015 TO FEBRUARY 2019 WERE INCLUDED. DEMOGRAPHIC DATA, DISEASE BURDEN, AND SURGICAL QUALITY ASSURANCE PARAMETERS WERE ANALYSED. MEDIAN AGE WAS 69 (IQR: 58¿76) WITH 14 WOMEN (66%) AND 7 MEN (33%). DISSECTION WAS PERFORMED WITH A HARMONIC SCALPEL (HARMONIC ACE®, JOHNSON & JOHNSON, NEW JERSEY, USA) FROM CAUDAL TO CRANIAL. THE DECISION TO LIGATE AND RESECT THE LONG SAPHENOUS VEIN DISTALLY AND AT THE SAPHENOFEMORAL JUNCTION WAS MADE INTRAOPERATIVELY BY THE RESECTING SURGEON BASED ON DISEASE BURDEN AND LOCATION. WHEREVER POSSIBLE, THE SPECIMEN WAS RESECTED EN BLOC AS A SINGLE PACKET. THE CAVITY WAS SUBSEQUENTLY IRRIGATED WITH STERILE WATER AND TWO 15 FRENCH BLAKE DRAINS (ETHICON, INC., NEW JERSEY, USA) WERE INSERTED INTO THE CAVITY PRIOR TO PORT-SITE WOUND CLOSURE. REPORTED COMPLICATIONS INCLUDED INFECTION (N=4), SEROMA (N=1), SKIN NECROSIS (N=1, FEMORAL NERVE PALSY, CELLULITIS IN CONCLUSION WE REPORT THE FIRST UK SERIES OF MILND IN A CUTANEOUS ONCOLOGY SERVICE. OUR RESULTS SHOW THAT MILND IS A SAFE TECHNIQUE THAT CAN BE INTRODUCED INTO A BUSY NHS PRACTICE WITH A STRUCTURED TRAINING PROGRAM, WITH SURGICAL QUALITY ASSURANCE OUTCOMES IDENTICAL TO OPEN INGUINAL LYMPHADENECTOMY. OUR LEARNING CURVE WAS SIMILAR TO PREVIOUSLY PUBLISHED DATA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2238407 BLAKE DRAIN UNKNOWN PRODUCT CATHETER, IRRIGATION GBX ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention