BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBTRYX SYSTEM

    MDR report key: 23018250 · Received September 10, 2025

    Report

    Report Number
    2124215-2025-63181
    Event Type
    Injury
    Date Received
    September 10, 2025
    Date of Event
    December 23, 2016
    Report Date
    September 10, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OTN
    UDI-DI
    08714729718994
    PMA / PMN Number
    K040787
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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) 2016, WAS CHOSEN AS A BEST ESTIMATE BASED ON THE DATE OF THE MESH WAS IMPLANTED. BLOCK D1, D4: BASED ON COURT DOCUMENTATION, THE DEVICE INVOLVED IN THE REPORTED EVENT IS LISTED AS ADVANTAGE MODEL: 850-2110; LOT: 0000041748. HOWEVER, THE PRODUCT DETAILS PROVIDED IN THE DOCUMENTATION CORRESPOND TO AN OBTRYX DEVICE. THE ADVANTAGE MODEL NUMBER CITED DOES NOT ALIGN WITH THE PRODUCT SPECIFICATIONS ASSOCIATED WITH THE OBTRYX PRODUCT FAMILY. THEREFORE, THE PRODUCT INFORMATION USED IN THIS REPORT IS BASED SOLELY ON THE DETAILS AVAILABLE IN THE COURT DOCUMENTS. BLOCK E1: THIS EVENT WAS REPORTED BY THE PATIENT'S LEGAL REPRESENTATION. THE IMPLANTING PHYSICIAN IS: DR. (B)(6). BLOCK H6: THE FOLLOWING IMDRF PATIENT CODE CAPTURE THE REPORTABLE EVENT OF: E2006 - CAPTURES THE REPORTABLE EVENT OF RECURRENT MESH EROSION. E230901 - CAPTURES THE REPORTABLE EVENT OF CALCIFICATION. E2330 - CAPTURES THE REPORTABLE EVENT OF PELVIC AND FLANK PAIN. E1311 - CAPTURES THE REPORTABLE EVENT OF WORSENING URINARY PROBLEMS. E1310 - CAPTURES THE REPORTABLE EVENT OF RECURRENT URINARY TRACT AND BLADDER INFECTIONS. E1906 - CAPTURES THE REPORTABLE EVENT OF BLADDER INFECTIONS. E0206 - CAPTURES THE REPORTABLE EVENT OF MENTAL ANGUISH. THE FOLLOWING IMDRF IMPACT CODE CAPTURE THE REPORTABLE EVENT OF: F12 - CAPTURES THE REPORTABLE EVENT OF THE PATIENT HAD FILED A LEGAL CLAIM FOR AN UNSPECIFIED PERSONAL INJURY RELATED TO THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN OBTRYX SYSTEM IMPLANTED DURING A PROCEDURE AND HAS SINCE EXPERIENCED COMPLICATIONS, INCLUDING RECURRENT MESH EROSIONS INTO THE URETHRA WITH CALCIFICATION, PELVIC AND FLANK PAIN, WORSENING URINARY ISSUES, RECURRENT URINARY TRACT AND BLADDER INFECTIONS, AND A LOSS OF ENJOYMENT OF LIFE. ADDITIONALLY, THE PATIENT CLAIMS THAT SHE HAS SUFFERED OR MAY IN THE FUTURE SUFFER DAMAGES SUCH AS PHYSICAL PAIN, MENTAL ANGUISH, PHYSICAL IMPAIRMENT, AND MEDICAL EXPENSES DUE TO THE IMPLANTATION OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2498680 OBTRYX SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR OTN BOSTON SCIENTIFIC CORPORATION M0068505001 0000041748 08714729718994

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other