BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARIETEX COMP 20X15CM W THR X1

    MDR report key: 6151390 · Received December 7, 2016

    Report

    Report Number
    9615742-2016-00192
    Event Type
    Malfunction
    Date Received
    December 7, 2016
    Report Date
    November 9, 2016
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    PMA / PMN Number
    K110815
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONTACT OFFICE PHONE NUMBER: (B)(4). SINCE THE LOT NUMBER WAS NOT PROVIDED, THIS INFORMATION CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    LITERATURE REVIEW CITATION: CITATION: OOMMEN, CN, NUNES, QM, SHAHZAD, K, SMART, N, TANDON, A (2016). PARIETEX¿ COMPOSITE MESH VERSUS DYNAMESH®-IPOM FOR LAPAROSCOPIC INCISIONAL AND VENTRAL HERNIA REPAIR: A RETROSPECTIVE COHORT STUDY. ROYAL COLLEGE OF SURGEONS, 6, 568-573. DOI: 10.1308/RCSANN.2016.0292 A TOTAL OF 88 PATIENTS UNDERWENT LAPARACOPIC INCISIONAL AND VENTRAL HERNIA REPAIR (LIVHR) BETWEEN JANUARY 2008 AND DECEMBER 2010. OF THESE, 82 PATIENTS UNDERWENT LAPAROSCOPIC INCISIONAL HERNIA REPAIR, 5 PATIENTS HAD A LAPAROSCOPY-ASSISTED PROCEDURE AND 1 HAD CONVERSION TO OPEN PROCEDURE; 39 PATIENTS WERE MALE AND 49 WERE FEMALE. MEDIAN FOLLOW-UP WAS 53.6 MONTHS (RANGE, 40-61 MONTHS). SEVENTY-FIVE PATIENTS (85.2%) PRESENTED WITH A PRIMARY INCISIONAL HERNIA, TEN (11.4%) PRESENTED WITH A FIRST RECURRENCE AND THREE (3.4%) PRESENTED WITH A SECOND RECURRENCE FROM THEIR PREVIOUS HERNIA REPAIRS. SIXTY-SIX PATIENTS (75%) HAD SINGLE DEFECT EITHER SMALLER THAN 4CM OR BETWEEN 4CM AND 10CM; TWENTY-TWO PATIENTS (25%) HAD MULTIPLE DEFECTS. TWENTY-SIX PATIENTS UNDERWENT LIVHR WITH A DYNAMESH-IPOM MESH, AND PARIETEX COMPOSITE MESH WAS USED IN 62 PATIENTS. THE MALE:FEMALE RATIO WAS 1:1.89 IN THE DYNAMESH-IPOM MESH GROUP AND 1:1.07 IN THE PARIETEX COMPOSITE MESH GROUP. BMI WAS HIGH IN 12 PATIENTS (46%) IN THE DYNAMESH-IPOM MESH GROUP AND IN 35 (56.45%) IN THE PARIETEX COMPOSITE MESH GROUP. IN 45 PATIENTS, ONLY PROTACK WAS USED TO FIX THE MESH, WHEREAS IN 43 PATIENTS BOTH PROTACK AND TRANSFASCIAL SUTURING WERE USED. INCIDENCE OF CONVERSION TO OPEN OPERATION WAS 1.1%. THERE WAS NO MORTALITY IN THE STUDY. OVERALL MORBIDITY WAS 20.5%. EIGHT PATIENTS (12.9%) IN THE PARIETEX COMPOSITE MESH GROUP DEVELOPED A RECURRENCE AND FOUR PATIENTS (6.4%) IN THE PARIETEX COMPOSITE MESH GROUP (P=0.185) DEVELOPED A SEROMA AND/OR HAEMATOMA. OF THESE, TWO PATIENTS DEVELOPED A HAEMATOMA IN THE EARLY POSTOPERATIVE PERIOD, WHICH WAS ASSESSED CLINICALLY AND WITH ULTRASOUND, AND TWO PATIENTS WERE DIAGNOSED WITH A SEROMA (THIS FTR IS FOR PATIENT #2) ON ULTRASOUND SCAN 6 WEEKS POSTOPERATIVELY, WHICH SETTLED SPONTANEOUSLY IN FOLLOW-UP AND REQUIRED NO FURTHER INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803777 PARIETEX COMP 20X15CM W THR X1 MESH, SURGICAL, POLYMERIC FTL SOFRADIM PRODUCTION PCO2015F

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR