BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH, SURGICAL, POLYMERIC

    MDR report key: 6661960 · Received June 22, 2017

    Report

    Report Number
    9615742-2017-05171
    Event Type
    Injury
    Date Received
    June 22, 2017
    Report Date
    June 15, 2017
    Manufacturer
    SOFRADIM PRODUCTION SAS
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    T.VERHAGEN, W.A.R, ZWAANS, M.J.A LOOS, J.A CHARBON, M.R.M. SCHELTINGA, R.M. H ROUMEN (JUNE 2016) RANDOMIZED CLINICAL TRIAL COMPARING SELF-GRIPPING MESH WITH A STANDARD POLYPROPYLENE MESH FOR OPEN INGUINAL HERNIA REPAIR. BRITISH JOURNAL OF SURGERY SOCIETY. VOLUME 103, ISSUE 7 PAGES 812- 818. DOI: 10.1002/BJS.10178. BACKGROUND:THE INTRODUCTION OF MESH FOR OPEN INGUINAL HERNIA REPAIR HAS REDUCED THE RATE OF RECURRENCE, ALLOWING RESEARCH TO FOCUS ON PREVENTION OF POSTOPERATIVE PAIN. IN AN EFFORT TO REDUCE CHRONIC PAIN, A SEMIRESORBABLE, LIGHTER AND SELF-GRIPPING MESH WAS DEVELOPED. METHODS: A DOUBLE-BLIND RANDOMIZED CLINICAL TRIAL WAS CONDUCTED COMPARING THE SELF-GRIPPING MESH WITH A STANDARD POLYPROPYLENE MESH REPAIR. PATIENTS OVER 18 YEARS OF AGE UNDERGOING OPEN PRIMARY HERNIA REPAIR WERE INCLUDED. PAIN WAS MEASURED ON A SIX-POINT VERBAL RATING SCALE (VRS) AND A 150-MM VISUAL ANALOGUE SCALE (VAS). POSTOPERATIVE PAIN REDUCTION FROM BASELINE PAIN (VAS), COMPLICATIONS AND RETURN TO WORK/HOBBIES WERE STUDIED. DATA WERE COLLECTED AT BASELINE, 3 WEEKS, 3 MONTHS AND 1 YEAR AFTER SURGERY (PRIMARY OUTCOME). AFTER 1 YEAR, TEN HERNIA RECURRENCES OBSERVED IN THE SELF-GRIPPING MESH GROUP. TWENTY FIVE PATIENTS IN THE SELF-GRIPPING MESH GROUP DEVELOPED EARLY AND LATE COMPLICATIONS (SEROMA, 4;HAEMATOMA, 12: SUPERFICIAL WOUND INFECTION, 3; DEEP WOUND INFECTION, 1; URINARY TRACT INFECTION, 1; URINARY RETENTION, 2. THIS REPORT IS FOR: - DEEP WOUND INFECTION (1).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441211 MESH, SURGICAL, POLYMERIC FTL SOFRADIM PRODUCTION SAS UNKNOWN PROGRIP UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other