BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAPRO MESH UNKNOWN PRODUCT

    MDR report key: 9281168 · Received November 5, 2019

    Report

    Report Number
    2210968-2019-89544
    Event Type
    Injury
    Date Received
    November 5, 2019
    Report Date
    October 14, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K033337
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: HERNIA; DOI: HTTPS://DOI.ORG/10.1007/S10029-018-1844-7. (B)(4).

    Description of Event or Problem · 1

    TITLE: SERUM C-REACTIVE PROTEIN LEVEL AFTER VENTRAL HERNIA REPAIR WITH MESH REINFORCEMENT CAN PREDICT INFECTIOUS COMPLICATIONS: A RETROSPECTIVE COHORT STUDY. THE AIM OF THIS PRESENT RETROSPECTIVELY STUDY WAS TO ANALYZE WHETHER POSTOPERATIVE BLOOD TEST RESULTS ARE A VALUABLE PREDICTOR OF INFECTIOUS COMPLICATIONS (ICS) AFTER HERNIA REPAIR WITH MESH REINFORCEMENT AND WHETHER THEY CAN AID IN EARLY DETECTION. BETWEEN 2008 AND 2011, 373 PATIENTS UNDERWENT CONVENTIONAL VENTRAL HERNIOPLASTY WITH MESH AUGMENTATION. CONVENTIONAL HERNIA REPAIRS WERE PERFORMED USING STANDARDIZED PROCEDURES. OF THESE PATIENTS, 51 (N=33 FEMALE AND N=18 MALE; AGE OF 63.9±11.1 YEARS; BMI OF 32.4±7.0) HAD INFECTIOUS COMPLICATIONS. MESH REINFORCEMENT FOR THESE PATIENTS INCLUDED OPTILENE (N=7), ULTRAPRO (N=43) AND OTHER BRAND OF MESH (N=1). PROCEDURE-RELATED INFECTIOUS COMPLICATION INCLUDED MESH SITE INFECTION (N=1). RISK FACTORS FOR ICS IN THE UNIVARIATE ANALYSIS WERE OBESITY, CARDIAC COMORBIDITY, AND FEMALE SEX, AS WELL AS THE SIZE OF THE MESH. THE POSITION AND TYPE OF THE MESH WERE NOT SIGNIFICANTLY DIFFERENT BETWEEN THE TWO GROUPS WITH AND WITHOUT IC. THE RESULTS INDICATE THAT POSTOPERATIVE SERUM C-REACTIVE PROTEIN (CRP) ALLOWS FOR EARLY PREDICTION OF THE POSTOPERATIVE COURSE. LOW CRP DURING THE INITIAL PODS IS ASSOCIATED WITH LOWER RISK OF ICS. HIGHER LEVELS ON POD 5 OR 6 BEHOOVE CLOSE SURVEILLANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1074257 ULTRAPRO MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention