BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH BALLYMONEY - IVS TUNNELLER¿

    MDR report key: 8886092 · Received August 12, 2019

    Report

    Report Number
    6000141-2019-00009
    Event Type
    Injury
    Date Received
    August 12, 2019
    Report Date
    August 12, 2019
    Manufacturer
    TYCO HEALTHCARE UK MANF. LTD
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: CAL-TS10 (LOT# 0297), UGYKA (LOT# ZGA00455), 481047 (LOT# 05B17-1) . IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF COMPLETE POST-HYS TERECTOMY VAULT PROLAPSE, PULSION ENTEROCELE, CYSTOURETHROCELE, STRESS URINARY INCONTINENCE. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE OUTCOME. THE DEVICE HAD BEEN USED WITH CAL-TS10 CALDERA T-SLING, LOT# 0297.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677933 MESH BALLYMONEY - IVS TUNNELLER¿ MESH, SURGICAL, POLYMERIC FTL TYCO HEALTHCARE UK MANF. LTD IVS02 05A249

    Patients

    Seq Age Sex Outcome Treatment
    1 Other