BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBTRYX SYSTEM - HALO

    MDR report key: 9262924 · Received October 31, 2019

    Report

    Report Number
    3005099803-2019-05230
    Event Type
    Injury
    Date Received
    October 31, 2019
    Date of Event
    March 17, 2011
    Report Date
    October 31, 2019
    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 · 1

    (B)(4). REPORT SOURCE: OTHER: HC ADVERSE INCIDENT REPORT REFERENCE (B)(4); SUBMITTED TO HC (HEALTH CANADA) BY THE PATIENT. THE COMPLAINT DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OBTRYX SYSTEM - HALO WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2011, SHE HAS EXPERIENCED FIBROMYALGIA, PAIN IN HER NERVES, AND MUSCLES WHICH IS, AS PER THE PATIENT, PROBABLY RELATED TO THE "OXIDATION OF THE STRIP," RADIATING BURNING SENSATION UNDER THE SKIN, RIGHT GROIN, RIGHT HIP, RIGHT LEG, TORN DISC IN HER BACK, AND THE FEELING OF EVERYTHING PULLS TO THE RIGHT SIDE INCLUDING HER PELVIS. SHE ALSO HAS EXPERIENCED BURSITIS, TENDINITIS, OTHER INFLAMMATION, EXTREME REDNESS ON HER VULVA WHICH SHE REPORTED TO BE A REACTION TO THE IMPLANT, AND IMMUNE RESPONSE DUE TO THE "FOREIGN BODY OF PLASTIC."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1055217 OBTRYX SYSTEM - HALO MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR OTN BOSTON SCIENTIFIC CORPORATION M0068505000 1ML0090703 08714729718987

    Patients

    Seq Age Sex Outcome Treatment
    1 Other