BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLAKE DRAIN UNKNOWN PRODUCT

    MDR report key: 11259445 · Received February 1, 2021

    Report

    Report Number
    2210968-2021-00875
    Event Type
    Injury
    Date Received
    February 1, 2021
    Date of Event
    January 24, 2020
    Report Date
    January 5, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GBX
    PMA / PMN Number
    CL I EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). 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. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS (BLAKE DRAIN) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS (INFECTION/WOUND INFECTION, WOUND NECROSIS) DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS (BLAKE DRAIN) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE IN-HOSPITAL MORTALITY/DEATH DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS (BLAKE DRAIN) USED IN THIS PROCEDURE? IF YES, PLEASE PROVIDE PATIENT DEMOGRAPHICS FOR THE PATIENTS THAT EXPERIENCED THE POST-OPERATIVE COMPLICATIONS (INFECTION/WOUND INFECTION, WOUND NECROSIS). IF YES, PLEASE PROVIDE PATIENT DEMOGRAPHICS FOR THE PATIENTS THAT EXPERIENCED THE POST-OPERATIVE COMPLICATIONS ( IN-HOSPITAL MORTALITY/DEATH). WERE THESE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. 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: HERNIA (2020) 24:495502. HTTPS://DOI.ORG/10.1007/S10029-019-02068-7. 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 · 1

    IT WAS REPORTED VIA A JOURNAL ARTICLE AND A DRAIN WAS USED. TITLE: COMPLEX ABDOMINAL WALL HERNIA REPAIR WITH BIOLOGIC MESH IN ELDERLY: A PROPENSITY MATCHED ANALYSIS AUTHORS: S. GOGNA, R. LATIFI, A. POLICASTRO, K. PRABHAKARAN, P. ANDERSON5, J. CON, J. CHOI, D. J. SAMSON8, J.BUTLER. CITATION: HERNIA (2020) 24:495502. HTTPS://DOI.ORG/10.1007/S10029-019-02068-7. THIS STUDY AIMED TO ANALYZE THE OUTCOMES OF THE ELDERLY COMPARED TO NON-ELDERLY UNDERGOING COMPLEX ABDOMINAL WALL RECONSTRUCTION (CAWR) USING BIOLOGICAL MESH AS REINFORCEMENT BY UTILIZING PROPENSITY SCORE MATCHING. THIS RETROSPECTIVE COHORT REVIEW INVOLVES 136 PATIENTS (73 FEMALE AND 63 MALE) WHO UNDERWENT CAWR USING A PORCINE DERIVED ACELLULAR DERMAL MATRIX FOR COMPLEX ABDOMINAL WALL HERNIA FROM 2014 TO 2016. THE PATIENT POPULATION WAS DIVIDED INTO TWO GROUPS; NON-ELDERLY GROUP INCLUDES 95 PATIENTS (50 MALE AND 45 FEMALE; AGE: 49.4 ¿ 11.3 YEARS; BMI 32.2¿10.3 KG/M2) WHO WERE AGED 1864 YEARS, AND ELDERLY GROUP INCLUDES 41 PATIENTS (13 MALE AND 28 FEMALE; AGE: 75.7 ¿ 6.8 YEARS; BMI: 31.0 ¿ 6.9 KG/M2) WHO WERE AGED = (B)(6) YEARS. DURING THE PROCEDURE, TWO OR THREE 19-FRENCH BLAKE DRAINS BELOW THE FASCIA-ADIPOCUATNEOUS FLAPS WERE PLACED. REPORTED COMPLICATIONS IN THE ELDERLY GROUP INCLUDED OVERALL INTRAOPERATIVE RATE/ INTRAOPERATIVE COMPLICATION, SURGICAL SITE INFECTION/WOUND INFECTION (N-3) IN WHICH WOUND DEBRIDEMENT WAS PERFORMED, WOUND NECROSIS (N-1) IN WHICH WOUND DEBRIDEMENT WAS PERFORMED. REPORTED COMPLICATIONS IN THE NON-ELDERLY GROUP INCLUDED OVERALL INTRAOPERATIVE RATE/INTRAOPERATIVE COMPLICATION,SURGICAL SITE INFECTION/WOUND INFECTION (N-6) IN WHICH WOUND DEBRIDEMENT WAS PERFORMED, WOUND NECROSIS (N-3) IN WHICH WOUND DEBRIDEMENT WAS PERFORMED. IN CONCLUSION, OUTCOMES AFTER CAWR WITH A BIOLOGICAL MESH DID NOT DIFFER BETWEEN ELDERLY AND NON-ELDERLY PATIENTS AND ADVANCED AGE DID NOT TRANSLATE INTO POOR OUTCOME AS COMPARED TO THE NON-ELDERLY. BASED ON THESE FINDINGS, ADVANCED AGE SHOULD NOT BE REGARDED AS AN ABSOLUTE OR RELATIVE CONTRAINDICATION TO CAWR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156726 BLAKE DRAIN UNKNOWN PRODUCT CATHETER, IRRIGATION GBX ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention