BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PARIETENE MESH PRODUCT

    MDR report key: 13593472 · Received February 24, 2022

    Report

    Report Number
    9615742-2022-00137
    Event Type
    Injury
    Date Received
    February 24, 2022
    Date of Event
    July 9, 2021
    Report Date
    February 24, 2022
    Manufacturer
    SOFRADIM PRODUCTION SAS
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    TITLE: ANATOMICAL AND CLINICAL OUTCOMES OF VAGINALLY ASSISTED LAPAROSCOPIC LATERAL SUSPENSION IN COMPARISON WITH LAPAROSCOPIC LATERAL SUSPENSION. SOURCE: CLIN. EXP. OBSTET. GYNECOL. 2021 VOL. 48(4), 935-941 PUBLISHED: 15 AUGUST 2021. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    TITLE: ANATOMICAL AND CLINICAL OUTCOMES OF VAGINALLY ASSISTED LAPAROSCOPIC LATERAL SUSPENSION IN COMPARISON WITH LAPAROSCOPIC LATERAL SUSPENSION. SOURCE: CLIN. EXP. OBSTET. GYNECOL. 2021 VOL. 48(4), 935-941 PUBLISHED: 15 AUGUST 2021. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE, A RETROSPECTIVE STUDY COMPARED THE OUTCOMES OF PATIENTS WITH STAGE 3-4 PELVIC ORGAN PROLAPSE WHO UNDERWENT VAGINALLY ASSISTED LAPAROSCOPIC LATERAL SUSPENSION AND LAPAROSCOPIC LATERAL SUSPENSION BETWEEN FEBRUARY 2013 AND MARCH 2020. IN BOTH GROUPS, MESH WAS USED AFTER BEING CUT INTO A T-SHAPE. THERE WERE 61 PATIENTS IN THE STUDY AND COMPLICATIONS INCLUDED: PROLAPSERECURRENCE, VAGINAL MESH EROSION AND DENOVO STRESS URINARY INCONTINENCE. MESH EROSION REQUIRED EXPOSED MESH EXCISION AND VAGINAL MUCOSA REPAIR. AGGRESSIVE DISSECTION, INTENSIVE CATHETERISATION, POOR SUTURE TECHNIQUES THAT DISRUPT THE NUTRITION OF THE MESH SITE, IMPROPER MESH PLACEMENT, AND SHRINKAGE OF THE MESH AT THE SUTURE STAGE. REOPERATION WAS REQUIRED TO TREAT STRESS URINARY INCONTINENCE AND RECURRENT PROLAPSE.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE, A RETROSPECTIVE STUDY COMPARED THE OUTCOMES OF PATIENTS WITH STAGE 3-4 PELVIC ORGAN PROLAPSE WHO UNDERWENT VAGINALLY ASSISTED LAPAROSCOPIC LATERAL SUSPENSION AND LAPAROSCOPIC LATERAL SUSPENSION BETWEEN FEBRUARY 2013 AND MARCH 2020. IN BOTH GROUPS, MESH WAS USED AFTER BEING CUT INTO A T-SHAPE. THERE WERE 61 PATIENTS IN THE STUDY AND COMPLICATIONS INCLUDED: PROLAPSERECURRENCE, VAGINAL MESH EROSION AND DENOVO STRESS URINARY INCONTINENCE. MESH EROSION REQUIRED EXPOSED MESH EXCISION AND VAGINAL MUCOSA REPAIR. AGGRESSIVE DISSECTION, INTENSIVE CATHETERISATION, POOR SUTURE TECHNIQUES THAT DISRUPT THE NUTRITION OF THE MESH SITE, IMPROPER MESH PLACEMENT, AND SHRINKAGE OF THE MESH AT THE SUTURE STAGE. REOPERATION WAS REQUIRED TO TREAT STRESS URINARY INCONTINENCE AND RECURRENT PROLAPSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225974 UNKNOWN PARIETENE MESH PRODUCT MESH, SURGICAL, POLYMERIC FTL SOFRADIM PRODUCTION SAS UNKNOWN PARIETENE MESH PRODUCT

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention