BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH BALLYMONEY - IVS TUNNELLER¿

    MDR report key: 14459438 · Received May 20, 2022

    Report

    Report Number
    9615742-2022-00467
    Event Type
    Injury
    Date Received
    May 20, 2022
    Report Date
    May 19, 2022
    Manufacturer
    SOFRADIM PRODUCTION SAS
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED IRRITABLE BOWEL SYNDROME, RECTOCELE, WEAKENED ANAL MUSCLES AND LEAKAGE ON OCCASION, DIFFICULTIES WITH BOWEL MOTIONS, CONSTIPATION, URINARY INCONTINENCE, CYSTOCELE, DYSPAREUNIA, ADHESIONS, ENDOMETRIOSIS, PELVIC TUMOURS OR FIBROIDS, VAGINAL PAIN, UTERINE PROLAPSE, VAGINAL VAULT PROLAPSE, PAIN, EMOTIONAL CHANGES, IMPAIRMENT OF ACTIVITIES, STAPHYLOCOCCUS AUREUS, VAGINAL DISCHARGE, URINARY INFECTION, LOSS OF LIBIDO, URINARY URGENCY, NOCTURIA, PROLAPSE, GENITOURINARY SYNDROME OF MENOPAUSE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MEDICATION, ANAL TEAR SURGERY, HYSTERECTOMY, HOSPITALIZATION, TESTOSTERONE REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581852 MESH BALLYMONEY - IVS TUNNELLER¿ MESH, SURGICAL, POLYMERIC FTL SOFRADIM PRODUCTION SAS UNKNOWN IVS TUNNELLER DEVICE

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| R| S