BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 12810699 · Received November 15, 2021

    Report

    Report Number
    2210968-2021-11414
    Event Type
    Injury
    Date Received
    November 15, 2021
    Date of Event
    July 21, 2020
    Report Date
    November 15, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. 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 ANY OF THE 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 ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE 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. (B)(4)¿ DEVICE NOT RETURNED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION CITE: IRISH JOURNAL OF MEDICAL SCIENCE (1971 -) (2021) 190:297¿305 HTTPS://DOI.ORG/10.1007/S11845-020-02321-4.

    Description of Event or Problem · 0

    TITLE: MODERN ONCOLOGICAL AND OPERATIVE OUTCOMES IN OESOPHAGEAL CANCER: THE ST. JAMES¿S HOSPITAL EXPERIENCE. PATIENTS UNDERGOING OESOPHAGEAL RESECTION BETWEEN JANUARY 2009 AND DECEMBER 2018 AT ST. JAMES¿S HOSPITAL, THE DESIGNATED NATIONAL CENTER FOR OESOPHAGEAL AND GASTRIC CANCER IN IRELAND, WERE PROSPECTIVELY STUDIED. THE STANDARD PROTOCOL ON THE DAY OF SURGERY INCLUDES A THORACIC EPIDURAL IN ALL PATIENTS, COMBINED WITH PATIENT CONTROLLED ANALGESIA, AND I.V. PARACETAMOL. RELATIVE INTRAOPERATIVE FLUID RESTRICTION IS THE STANDARD OF CARE, APPROXIMATELY 500 ML/H. ALL ANASTOMOSES ARE SUTURED USING A STANDARDIZED APPROACH WITH ONE LAYER OF INTERRUPTED 3.0 PDS (POLYDIOXANONE) SUTURES (ETHICON, JOHNSON & JOHNSON, DUBLIN, IRELAND). PATIENTS ARE EXTUBATED IMMEDIATELY AFTER SURGERY AND MANAGED IN A HIGH DEPENDENCY UNIT OR INTENSIVE CARE UNIT (HDU/ICU) FOR A MINIMUM OF 24 H BEFORE TRANSFER TO A SPECIALIST SURGICAL WARD. REPORTED COMPLICATIONS INCLUDED ANASTOMOTIC LEAK (N=20),GASTRIC CONDUIT NECROSIS (N=6) , CHYLE LEAK (N=25), RESPIRATORY INFECTION (N=98). IN CONCLUSION CONSISTENT WITH REGISTRY DATA ON POPULATION SURVIVAL FOR OESOPHAGEAL CANCER, THIS STUDY HIGHLIGHTS MARKEDLY IMPROVED SURVIVAL OUTCOMES IN PATIENTS TREATED CURATIVELY, REFLECTING INTERNATIONAL TRENDS, AS WELL AS LOW MORTALITY RATES; HOWEVER, CARDIORESPIRATORY COMPLICATIONS REMAIN SIGNIFICANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1713981 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention