BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBTRYX II SYSTEM - CURVED

    MDR report key: 8820988 · Received July 24, 2019

    Report

    Report Number
    3005099803-2019-03696
    Event Type
    Injury
    Date Received
    July 24, 2019
    Date of Event
    September 2, 2016
    Report Date
    July 24, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OTN
    UDI-DI
    08714729839255
    PMA / PMN Number
    K121754
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT WAS APPROXIMATED TO (B)(6) 2016, IMPLANT DATE, AS NO EVENT DATE WAS REPORTED. THIS COMPLAINT WAS REPORTED BY THE PATIENT'S LAWYER. THE DEVICE WAS IMPLANTED BY (B)(6) AT (B)(6) MEDICAL CENTER, (B)(6). (B)(4). ALTHOUGH THE CURRENT MANUFACTURING SITE FOR OBTRYX SLINGS IS BOSTON SCIENTIFIC IN (B)(4), THE REPORTED LOT INVOLVED IN THIS COMPLAINT WAS MANUFACTURED BY: FREUDENBERG MEDICAL, (B)(4). 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 A OBTRYX II SYSTEM - CURVED DEVICE WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, AFTER THE PROCEDURE, THE PATIENT HAS SUFFERED INJURIES AS A RESULT OF THE IMPLANTATION OF THE DEVICE. THESE INJURIES INCLUDE SEVERE PELVIC PAIN, LEG AND INNER THIGH PAIN, DYSPAREUNIA, AND FURTHER URINARY PROBLEMS. THE PATIENT ALSO CLAIMS TO HAVE SUFFERED DAMAGES SUCH AS PHYSICAL PAIN AND MENTAL ANGUISH SUSTAINED IN THE PAST, PHYSICAL PAIN AND MENTAL ANGUISH THAT THE PATIENT WILL PROBABLY SUSTAIN IN THE FUTURE, PHYSICAL IMPAIRMENT SUSTAINED IN THE PAST, PHYSICAL IMPAIRMENT THAT THE PATIENT WILL PROBABLY SUSTAIN IN THE FUTURE, MEDICAL CARE EXPENSES INCURRED IN THE PAST, AND MEDICAL CARE EXPENSES THAT THE PATIENT WILL PROBABLY INCUR IN THE FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616314 OBTRYX II SYSTEM - CURVED MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR OTN BOSTON SCIENTIFIC CORPORATION M0068504110 0000037832 08714729839255

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention