BEUDAMED
    FDA Adverse Event Death Summary report: N

    MERSILENE POLYESTER FIBER SUTURE UNKNOWN PRODUCT

    MDR report key: 11175380 · Received January 14, 2021

    Report

    Report Number
    2210968-2021-00377
    Event Type
    Death
    Date Received
    January 14, 2021
    Date of Event
    April 7, 2020
    Report Date
    January 5, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SG
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DATE SENT TO THE FDA: 01/15/2021. 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.

    Additional Manufacturer Narrative · 0

    DATE SENT TO THE FDA: 01/25/2021. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: ANSWER: THANK YOU FOR YOUR EMAIL.THERE WAS NO DEFICIENCY WITH THE PRODUCT AND THE PRODUCT IS NOT INVOLVED WITH THE PROGNOSIS OF THE PATIENT. WE PRECISED THAT THE PATIENT WAS AGED, HAD NECROSIS, AND CONSULTED AT A LATE STAGE AND THESE FACTS EXPLAINED THE DEATH. DOES THE AUTHOR/SURGEON BELIEVE THAT ETHICON PRODUCT (MERSILENE SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO MULTI-VISCERAL FAILURE AND PATIENT¿S DEATH DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCT (MERSILENE SUTURE) USED IN THIS PROCEDURE (A RIGHT HEMI-COLECTOMY WITH AN ILEO-COLIC ANASTOMOSIS) ? WAS THIS DEATH CASE DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. 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.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT (B)(4). DATE SENT TO THE FDA: 01/14/2020 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. 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. ATTEMPTS ARE BEING MADE TO OBTAIN THE ADDITIONAL INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE AUTHOR/SURGEON BELIEVE THAT ETHICON PRODUCT (MERSILENE SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO MULTI-VISCERAL FAILURE AND PATIENT¿S DEATH DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCT (MERSILENE SUTURE) USED IN THIS PROCEDURE (A RIGHT HEMI-COLECTOMY WITH AN ILEO-COLIC ANASTOMOSIS) ? WAS THIS DEATH CASE DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. WOULD THE JOURNAL AUTHOR LIKE TO SPEAK WITH ETHICON MEDICAL SAFETY AND ENGINEERING VIA SCHEDULED CONFERENCE CALL REGARDING THE PRODUCT INVOLVED IN THIS EVENT? CITATION: JOURNAL OF SURGICAL CASE REPORTS, 2020;6, 1¿3 DOI: 10.1093/JSCR/RJAA115 PLEASE SEE ARTICLE ATTACHED.

    Description of Event or Problem · 1

    TITLE: STRANGULATED SPIGELIAN HERNIA WITH NECROSIS OF THE CAECUM, APPENDIX AND TERMINAL .ILEUM: AN UNUSUAL PRESENTATION IN THE ELDERLY. THIS CASE STUDY REPORTS AN UNUSUAL CASE OF A STRANGULATED SPIGELIAN HERNIA WITH NECROTIC CONTENTS OF THE CAECUM, APPENDIX, AND TERMINAL ILEUM IN THE ELDERLY. AN (B)(6) YEAR-OLD WOMAN, WITH A HISTORY OF EIGHT PREGNANCIES WERE ADMITTED FOR BOWEL OBSTRUCTION EVOLVING FOR 7 DAYS. THE COMPUTED TOMOGRAPHY (CT) SCAN SHOWED A STRANGULATED RIGHT SPIGELIAN HERNIA WITH SIGNS OF BOWEL ISCHEMIA, PNEUMATOSIS AND MINIMAL PERITONEAL EFFUSION. SURGICAL EXPLORATION REVEALED EXTENSIVE NECROSIS OF THE HERNIAL SAC AND ITS CONTENTS (CAECUM, APPENDIX AND THE 10CM OF THE TERMINAL ILEUM). A RIGHT HEMI-COLECTOMY WITH AN ILEO-COLIC ANASTOMOSIS WAS PERFORMED IN WHICH THE PARIETAL DEFECT WAS CLOSED BY APONEURORRAPHY WITH MERSUTURE 0 (ETHICON). THE POST-OPERATIVE COURSE WAS MARKED BY THE DEATH OF THE PATIENT IN THE INTENSIVE CARE DUE TO MULTI-VISCERAL FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71111 MERSILENE POLYESTER FIBER SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1