BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBTRYX SYSTEM - HALO

    MDR report key: 15855059 · Received November 23, 2022

    Report

    Report Number
    3005099803-2022-06962
    Event Type
    Injury
    Date Received
    November 23, 2022
    Date of Event
    April 27, 2019
    Report Date
    November 23, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OTN
    UDI-DI
    08714729718987
    PMA / PMN Number
    K040787
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OBTRYX SYSTEM - HALO DEVICE WAS IMPLANTED INTO THE PATIENT ON (B)(6) 2018 FOR THE TREATMENT OF URINARY INCONTINENCE. AFTER DEVICE IMPLANTATION, THE PATIENT EXPERIENCED PROBLEMS SHE BELIEVES WERE CAUSED BY THE OBTRYX DEVICE, SUCH AS BACK PAIN, HIP PAIN, RIGHT GROIN PAIN, AND CONSTANT PAIN IN THE GLUTES. SHE REPORTED THAT SINCE IMPLANTATION OF THE DEVICE, HER HEALTH HAS BEEN DETERIORATING FROM YEAR TO YEAR. PAINKILLERS SUCH AS NAPROXEN NO LONGER WORK, AND SHE INTENDS TO HAVE THE DEVICE REMOVED, AS SHE FEELS IT IS RUINING HER LIFE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309048 OBTRYX SYSTEM - HALO MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR OTN BOSTON SCIENTIFIC CORPORATION M0068505000 0021994985 08714729718987

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Unknown Required Intervention