BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    MDR report key: 7935785 · Received October 4, 2018

    Report

    Report Number
    2210968-2018-76326
    Event Type
    Injury
    Date Received
    October 4, 2018
    Report Date
    September 10, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 FOLLOWING INFORMATION. IF FURTHER DETAILS ARE RECEIVED AT THE 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 CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS USED IN THIS PROCEDURE? CITATION: JOURNAL OF SURGICAL RESEARCH 187 (2014) 122-127; DOI: HTTP://DX.DOI.ORG/10.1016/J.JSS.2013.09.032. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE "TITLE: FLUID VOLUME OVERLOAD NEGATIVELY INFLUENCES DELAYED PRIMARY FACIAL CLOSURE IN OPEN ABDOMEN MANAGEMENT" AUTHORS: QIAN HUANG, MD, RISHENG ZHAO, MD, CHAO YUE, MD, WEI WANG, MD, YUNZHAO ZHAO, MD, JIANAN REN, MD, NING LI, MD, AND JIE SHOU LI, MD CITATION: JOURNAL OF SURGICAL RESEARCH 187 (2014) 122-127; DOI: HTTP://DX.DOI.ORG/10.1016/J.JSS.2013.09.032. THIS RETROSPECTIVE SINGLE-CENTER STUDY AIMED TO EXPLORE THE INFLUENCE OF FLUID VOLUME OVERLOAD ON THE APPLICATION OF VACUUM-ASSISTED AND MESH-MEDIATED FASCIAL TRACTION (VAWCM) IN OA TREATMENT. BETWEEN JAN 2006 AND NOV 2011, 40 PATIENTS (N=30 MALE AND N=10 FEMALE; MEAN AGE OF 45±10.1 YEARS) UNDERWENT OPEN ABDOMEN MANAGEMENT FOR DIFFUSE PERITONITIS (N=16), SEVERE PANCREATITIS (N=8), SEVERE TRAUMA (N=12), AND PERITONEAL CAVITY HEMORRHAGE (N=4). IN THE VAWCM, A STERILE PERFORATED PLASTIC SHEET WAS PLACED INTRA-ABDOMINALLY TO COVER THE VISCERA AND THEN AN OVAL-SHAPED PROLENE MESH WAS SUTURED TO THE FASCIAL EDGES WITH A RUNNING 0 MONOFILAMENT SUTURE. POST-TREATMENT, OUTCOMES INCLUDED INTESTINAL FISTULA (N=10), INTRA-ABDOMINAL ABSCESS (N=15), FLUID OVERLOAD OF <20% (N=34), AND FLUID OVERLOAD OF =20% (N=6). EXITING THE OPERATIVE THEATER BEFORE COMPLETING ALL DEFINITIVE REPAIRS WAS THOUGHT TO RESULT IN INCREASED INTRA-ABDOMINAL ABSCESS, INTESTINAL FISTULAS, MULTI-ORGAN DYSFUNCTION, AND MORTALITY. IN THE PRESENT STUDY, THERE WAS A CLEAR DECREASE IN INTRA-ABDOMINAL PRESSURE AFTER VAWCM (FROM 20±8.7 MMHG TO 11±4.5 MMHG). VAWCM ENHANCED THE RATE OF DELAYED PRIMARY FASCIAL CLOSURE IN OA TREATMENT. FLUID VOLUME OVERLOAD NEGATIVELY INFLUENCES DELAYED PRIMARY FACIAL CLOSURE, AND JUDICIOUS INTRAVENOUS FLUID RESUSCITATION SHOULD BE ADVOCATED IN THE THERAPY OF CRITICALLY ILL PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774438 PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention