BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBTRYX SYSTEM - HALO

    MDR report key: 15459173 · Received September 20, 2022

    Report

    Report Number
    3005099803-2022-05322
    Event Type
    Injury
    Date Received
    September 20, 2022
    Date of Event
    February 20, 2014
    Report Date
    September 20, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OTN
    UDI-DI
    08714729718987
    PMA / PMN Number
    K040787
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: DATE OF EVENT WAS APPROXIMATED TO (B)(6) 2014, THE DATE THE SLING WAS IMPLANTED, AS NO EVENT DATE WAS REPORTED. THIS EVENT WAS REPORTED BY THE PATIENT'S LEGAL REPRESENTATIVE. THE IMPLANT SURGEON IS: (B)(6). (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OBTRYX HALO SINGLE SYSTEM DEVICE WAS IMPLANTED DURING A VAGINAL HYSTERECTOMY, ANTERIOR AND POSTERIOR REPAIRS, AND URETHRAL SLING INSERTION PROCEDURE PERFORMED ON (B)(6) 2014, FOR THE TREATMENT OF UTERINE VAGINAL PROLAPSE AND STRESS URINARY INCONTINENCE. ON (B)(6) 2019, THE PATIENT HAD A CONSULTATION. SHE MENTIONED THAT SHE HAD PAIN AND REPORTED THAT SHE HAD DISC BULGE. ADDITIONALLY, SHE STATED THAT HER PHYSICAL JOB HAD A LOT OF PUSHING AND PULLING. AFTER SEEING HER GYNECOLOGIST, IT WAS DISCUSSED THAT SHE HAD TO INCREASE HER PHYSICAL ACTIVITY FOR INCREASING STABILITY AND STRENGTH AROUND SPINE AND PELVIS. URINARY INCONTINENCE WAS NOT A PROBLEM FOR HER THIS TIME AND SHE STILL HAD BOWEL ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1603311 OBTRYX SYSTEM - HALO MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR OTN BOSTON SCIENTIFIC CORPORATION M0068505000 ML00001914 08714729718987

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Other