BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PROGRIP MESH PRODUCT

    MDR report key: 12060649 · Received June 24, 2021

    Report

    Report Number
    9615742-2021-01552
    Event Type
    Injury
    Date Received
    June 24, 2021
    Date of Event
    July 3, 2017
    Report Date
    June 24, 2021
    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

    TITLE: LONG TERM RESULTS OF OPEN COMPLEX ABDOMINAL WALL HERNIA REPAIR WITH SELF-GRIPPING MESH: A RETROSPECTIVE COHORT STUDY SOURCE: HTTP://DX.DOI.ORG/10.1016/J.IJSU.2017.07.029 1743-9191/© 2017 IJS PUBLISHING GROUP LTD. PUBLISHED BY ELSEVIER LTD. (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO A LITERATURE SOURCE OF STUDY PERFORMED BETWEEN JUNE 2012 AND JUNE 2015, THAT EVALUATED THE SAFETY AND FEASIBILITY OF THE SELF-GRIPPING POLYESTER MESH IN RETROMUSCULAR POSITION FOR THE TREATMENT OF COMPLEX ABDOMINAL WALL HERNIA REPAIR. A TOTAL OF 46 PATIENTS WERE TREATED IN NETHERLANDS WERE INCLUDED. AMONG THEM, 40 PATIENTS (87%) WERE DIAGNOSED WITH INCISIONAL HERNIA. SEVEN PATIENTS (18%) HAD INCISIONAL HERNIA COMBINED WITH ANOTHER HERNIA. FOUR PATIENTS (8.7%) HAD AN UMBILICAL HERNIA, ONE PATIENT (2.2%) HAD AN EPIGASTRIC HERNIA AND ONE PATIENT (2.2%) HAD RECTUS DIASTASIS. ALL HERNIAS WERE CONSIDERED AS COMPLEX. CONSIDERING THE SHORT-TERM FOLLOW-UP (THREE MONTHS): THREE PATIENTS HAD ADVERSE EVENTS DURING PRIMARY HOSPITAL ADMISSION. ONE PATIENT HAD AN EXTENDED HOSPITAL STAY OF 17 DAYS BECAUSE OF POSTOPERATIVE ILEUS, WHICH WAS TREATED CONSERVATIVELY; ONE SUFFERED FROM POSTOPERATIVE ANGINA PECTORIS, ONE PATIENT HAD POSTOPERATIVE PNEUMONIA, AND WAS SUCCESSFULLY TREATED WITH ANTIBIOTICS. TEN PATIENTS (21.7%) WERE DIAGNOSED WITH A POSTOPERATIVE SEROMA. ONE WAS TREATED WITH AN ULTRASOUND-GUIDED PUNCTURE AND NINE PATIENTS WERE TREATED CONSERVATIVELY. FIVE PATIENTS SHOWED AN ADVERSE EVENT DURING OUTPATIENT FOLLOW-UP. ONE PATIENT SHOWED A HEMATOMA WHICH WAS TREATED CONSERVATIVELY. FOUR PATIENTS WERE READMITTED TO THE HOSPITAL FOR VARIOUS REASONS. TWO WERE READMITTED FOR 11 DAYS AND 5 DAYS RESPECTIVELY BECAUSE OF ADMINISTERING INTRAVENOUS ANTIBIOTICS FOR THE TREATMENT OF WOUND INFECTION. IN ONE PATIENT THIS INFECTION RESULTED IN A MESH INFECTION, WHICH WAS TREATED CONSERVATIVELY. THE OTHER TWO PATIENTS WERE READMITTED FOR DIAGNOSTIC IMAGING OF LATE ABDOMINAL COMPLAINTS AND ILEUS, WHICH COULD NOT BE EXPLAINED BY THE SURGICAL INTERVENTION. CONSIDERING THE LONG-TERM FOLLOW-UP, ONE PATIENT (2.6%) HAD A MESH INFECTION AFTER 4 MONTHS REQUIRING MESH EXPLANTATION AND IMPLANTATION OF A BIOLOGICAL MESH. CONSIDERING THE SHORT-TERM FOLLOW-UP (THREE MONTHS): THE MEDIAN FOLLOW-UP WAS 15 WEEKS (INTER QUARTILE RANGE; IQR: 7-19 MONTHS) IN WHICH THE MEDIAN NUMBER OF OUTPATIENT CLINIC VISITS WAS 3 (IQR: 2-4). NONE (0%) OF THE 46 PATIENTS HAD A RECURRENCE DURING THIS PERIOD. AT THE OUTPATIENT CLINIC 38 PATIENTS (82.6%) WERE WITHOUT PAIN. THREE PATIENTS (6.5%) HAD MILD ABDOMINAL PAIN WITHOUT USE OF ANALGESICS; FOUR PATIENTS (8.7%) USED ANALGESICS DAILY FOR MODERATE ABDOMINAL PAIN. ONE OF THE PATIENTS (2.2%) SUFFERED FROM SEVERE PAIN. LONG TERM FOLLOW UP (ONE YEAR OR MORE): THIRTY-NINE PATIENTS (85%) WERE INCLUDED FOR LONG TERM FOLLOW UP, MEDIAN FOLLOW UP WAS 25 MONTHS (IQR: 19-35 MONTHS). MEDIAN NUMBER OF DOCTORS' VISITS CONCERNING HERNIA COMPLAINTS WAS 0 (IQR 0-2). IN TOTAL TWO PATIENTS (5.1%) HAD A RECURRENCE. ONE OF THESE PATIENTS HAD A PSEUDOBURSA AND RECURRENCE AFTER 17 MONTHS REQUIRING REOPERATION. THE OTHER PATIENT HAD A RECURRENCE AFTER 19 MONTHS REQUIRING REOPERATION. THIRTY PATIENTS (77%) REPORTED NO PAIN. NINE PATIENTS (23%) REPORTED PAIN COMPLAINTS WITH A MEAN VISUAL ANALOGUE SCALE (VAS) SCORE OF 1.7 (RANGE: 1-3).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    957780 UNKNOWN PROGRIP MESH PRODUCT MESH, SURGICAL, POLYMERIC FTL SOFRADIM PRODUCTION SAS UNKNOWN PROGRIP MESH PRODUCT

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R