BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBTRYX II SYSTEM - HALO

    MDR report key: 17196282 · Received June 25, 2023

    Report

    Report Number
    3005099803-2023-03291
    Event Type
    Injury
    Date Received
    June 25, 2023
    Date of Event
    September 11, 2018
    Report Date
    June 25, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OTN
    UDI-DI
    08714729837565
    PMA / PMN Number
    K121754
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3 DATE OF EVENT: DATE OF EVENT WAS APPROXIMATED TO (B)(6) 2018, IMPLANT DATE, AS NO EVENT DATE WAS REPORTED. BLOCK E1: THIS EVENT WAS REPORTED BY THE PATIENT'S LEGAL REPRESENTATION. THE IMPLANT SURGEON IS: (B)(6). BLOCK H6: IMDRF PATIENT CODES E2330, E2401, E232401 AND E1301 CAPTURE THE REPORTABLE EVENTS OF PELVIC PAIN, BACK PAIN, PAIN AND SUFFERING, PHYSICAL IMPAIRMENT, BOWEL DYSFUNCTION AND DYSURIA. IMDRF IMPACT CODE F1204 CAPTURES THE REPORTABLE EVENT OF PHYSICAL PERMANENT INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OBTRYX II SYSTEM - HALO DEVICE WAS IMPLANTED INTO THE PATIENT DURING A PROCEDURE PERFORMED ON (B)(6) 2018. POSTOPERATIVELY, THE PATIENT CLAIMED TO HAVE SUFFERED PELVIC PAIN, BACK PAIN, FAILED SLING, URINARY INCONTINENCE, BOWEL DYSFUNCTION, DYSURIA, AND MORE TO BE DETERMINED IN THE COURSE OF DISCOVERY. SHE HAD ALSO SUFFERED PAIN AND SUFFERING, LOSS OF ENJOYMENT OF LIFE, ANXIETY, DEPRESSION, PHYSICAL IMPAIRMENT, PERMANENT PHYSICAL INJURY AND MORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1453562 OBTRYX II SYSTEM - HALO MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR OTN BOSTON SCIENTIFIC CORPORATION M0068505110 0021581004 08714729837565

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other