BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBTRYX? II SYSTEM - HALO

    MDR report key: 23871402 · Received December 22, 2025

    Report

    Report Number
    2124215-2025-92421
    Event Type
    Injury
    Date Received
    December 22, 2025
    Date of Event
    January 23, 2020
    Report Date
    December 22, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OTN
    UDI-DI
    08714729837565
    PMA / PMN Number
    K121754
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3 DATE OF EVENT: THE EXACT EVENT ONSET DATE IS UNKNOWN. THE PROVIDED EVENT DATE OF (B)(6) 2020, WAS CHOSEN AS A BEST ESTIMATE BASED ON THE DATE OF THE MESH WAS IMPLANTED. BLOCK E1: THIS EVENT WAS REPORTED BY THE PATIENT'S LEGAL REPRESENTATION. THE IMPLANTING SURGEON IS: (B)(6). THE REVISING PHYSICIAN: (B)(6). BLOCK H6: THE FOLLOWING IMDRF PATIENT CODES CAPTURE THE REPORTABLE EVENTS OF: E1906 - CAPTURES THE REPORTABLE EVENT OF INFECTION. E2330 - CAPTURES THE REPORTABLE EVENT OF SEVERE PELVIC CRAMPING AND PAIN. E0506 - CAPTURES THE REPORTABLE EVENT OF BLEEDING. E2327 - CAPTURES THE REPORTABLE EVENT OF NECROTIC TISSUE. E231501 - CAPTURES THE REPORTABLE EVENT OF PURULENT DISCHARGE. E172001 - CAPTURES THE REPORTABLE EVENT OF ABSCESS. E2308 - CAPTURES THE REPORTABLE EVENT OF DISFIGUREMENT. E0206 - CAPTURES THE REPORTABLE EVENT OF EMBARRASSMENT AND MENTAL PAIN. E2401 - CAPTURES THE REPORTABLE EVENT OF SEVERE AND DEBILITATING INJURIES. THE FOLLOWING IMDRF IMPACT CODE CAPTURES THE REPORTABLE EVENT OF: F1905 - CAPTURES THE REPORTABLE EVENT OF REVISION SURGERY. F1901 - CAPTURES THE REPORTABLE EVENT OF REMOVAL AND DEBRIDEMENT OF NECROTIC TISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN OBTRYX II SYSTEM - HALO IMPLANTED DURING A PROCEDURE AND HAS SINCE EXPERIENCED COMPLICATIONS, INCLUDING INFECTION, SEVERE PELVIC CRAMPING AND PAIN, BLEEDING, PURULENCE, NECROTIC TISSUE, ABSCESS, RECURRENCE, REMOVAL AND DEBRIDEMENT OF NECROTIC TISSUE, AND SUBSEQUENT REMOVAL SURGERY. THE PATIENT LATER UNDERWENT A REVISION SURGERY ON OR ABOUT (B)(6) 2024. AS A RESULT OF THE IMPLANTED DEVICE, THE PATIENT SUFFERED SIGNIFICANT PAIN, UNNECESSARY EXPENSES, EMBARRASSMENT, DISFIGUREMENT, AND HARM. ADDITIONALLY, THE PATIENT CLAIMS THAT SHE MAY HAVE TO UNDERGO FURTHER SURGERY AND MAY, IN THE FUTURE, SUFFER DAMAGES SUCH AS SEVERE AND DEBILITATING INJURIES, SERIOUS BODILY HARM, MENTAL AND PHYSICAL PAIN AND SUFFERING, AND ADDITIONAL MEDICAL EXPENSES RELATED TO THE IMPLANTATION OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1745700 OBTRYX? II SYSTEM - HALO MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR OTN BOSTON SCIENTIFIC CORPORATION M0068505110 0023299265 08714729837565

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention