BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UPSYLON

    MDR report key: 16292520 · Received February 3, 2023

    Report

    Report Number
    3005099803-2023-00167
    Event Type
    Injury
    Date Received
    February 3, 2023
    Date of Event
    February 23, 2016
    Report Date
    February 2, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OTO
    UDI-DI
    08714729839217
    PMA / PMN Number
    K122794
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT WAS APPROXIMATED TO (B)(6) 2016, REVISION PROCEDURE DATE, AS NO EVENT DATE WAS REPORTED. THIS COMPLAINT WAS RECEIVED AS LITIGATION FROM A LEGAL SOURCE IN (B)(6). THIS EVENT WAS REPORTED BY THE PATIENT'S LEGAL REPRESENTATION. THE IMPLANTING SURGEON IS (B)(6). REVISION SURGERY PERFORMED BY (B)(6). PATIENT CODE E2006 CAPTURES THE REPORTABLE EVENT OF EXTRUSION. PATIENT CODE E1311 CAPTURES THE REPORTABLE EVENT OF UNSPECIFIED KIDNEY OR URINARY PROBLEM. PATIENT CODE E211401 CAPTURES THE REPORTABLE EVENT OF INTERNAL ORGAN PERFORATION. IMPACT CODE F1905 CAPTURES THE REPORTABLE EVENT OF DEVICE REVISION PROCEDURE PERFORMED. IMPACT CODE F12 HAS BEEN USED IN THE LIGHT OF THIS PATIENT SEEKING LEGAL RECOURSE FOR A PERSONAL INJURY RELATED TO THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC THAT AN UPSYLON Y-MESH WAS IMPLANTED DURING A LAPAROSCOPIC, SACROCOPLOPEXY, CYSTOSCOPY AND VAGINAL REPAIR PROCEDURES PERFORMED ON (B)(6) 2015 TO TREAT A PATIENT WITH VAGINAL PROLAPSE, AND SIMPLE RIGHT OVARIAN CYST. DURING THE SACROCOLPOPEXY, THERE WAS AN INADVERTENT 1.5 CM BLADDER PERFORATION THAT WAS SUBSEQUENTLY SUTURED WITH 2.0 VICRYL IN TWO LAYERS. THERE WERE NO OTHER PATIENT COMPLICATIONS REPORTED AT THE CONCLUSION OF THE PROCEDURE. ON (B)(6) 2016, THE PATIENT WAS SEEN AND EXAMINED. UPON EXAMINATION UNDER ANESTHESIA, IT WAS NOTED THAT THERE WAS A SUTURE EXPOSURE ON THE ANTERIOR WALL ABOUT 1.5 CM FROM THE URETHRAL MEATUS. THE PATIENT UNDERWENT A MINOR MESH EXCISION, AND CYSTOSCOPY WITH BIOPSY PROCEDURES. THERE WERE NO OTHER PATIENT COMPLICATIONS NOTED AT THE CONCLUSION OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823181 UPSYLON MESH, SURGICAL, SYNTHETIC OTO BOSTON SCIENTIFIC CORPORATION M0068318200 C002594 08714729839217

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Required Intervention