BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UPSYLON

    MDR report key: 21041285 · Received December 30, 2024

    Report

    Report Number
    2124215-2024-80137
    Event Type
    Injury
    Date Received
    December 30, 2024
    Date of Event
    May 14, 2024
    Report Date
    August 27, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OTO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK A2: THE EXACT AGE OF THE PATIENT IS UNKNOWN. HOWEVER, IT WAS REPORTED THE PATIENT WAS AROUND 61-70 YEARS OLD. BLOCK B3: DATE OF EVENT WAS APPROXIMATED TO MAY 14, 2024, IMPLANT DATE, AS NO EVENT DATE WAS REPORTED. BLOCKS D4, H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE UPN AND LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. BLOCK H6: PATIENT CODE E211401 CAPTURES THE REPORTABLE EVENT OF HOLE IN VAGINA. PATIENT CODE E2006 CAPTURES THE REPORTABLE EVENT OF MESH EXPOSURE IN THE VAGINA. IMPACT CODE F1901 CAPTURES THE REPORTABLE EVENT OF ADDITIONAL SURGERY.

    Additional Manufacturer Narrative · 0

    BLOCK H2 CORRECTION: BLOCK D2B PRO CODE HAS BEEN UPDATED. BLOCK A2: THE EXACT AGE OF THE PATIENT IS UNKNOWN. HOWEVER, IT WAS REPORTED THE PATIENT WAS AROUND 61-70 YEARS OLD. BLOCK B3: DATE OF EVENT WAS APPROXIMATED TO MAY 14, 2024, IMPLANT DATE, AS NO EVENT DATE WAS REPORTED. BLOCKS D4, H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE UPN AND LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. BASED ON THE NATURE OF THE INFORMATION PROVIDED TO BSC, IT IS NOT POSSIBLE TO PERFORM A GOOD FAITH EFFORT TO OBTAIN ADDITIONAL INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. BLOCK H6: PATIENT CODE E211401 CAPTURES THE REPORTABLE EVENT OF HOLE IN VAGINA. PATIENT CODE E2006 CAPTURES THE REPORTABLE EVENT OF MESH EXPOSURE IN THE VAGINA. IMPACT CODE F1901 CAPTURES THE REPORTABLE EVENT OF ADDITIONAL SURGERY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING Y-MESH PLACEMENT, A HOLE IN THE VAGINA WAS NOTED. DURING A FOLLOW-UP, A MESH EXPOSURE IN THE VAGINA WAS ALSO NOTED AND WAS TREATED THROUGH A SURGERY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING Y-MESH PLACEMENT, A HOLE IN THE VAGINA WAS NOTED. DURING A FOLLOW-UP, A MESH EXPOSURE IN THE VAGINA WAS ALSO NOTED AND WAS TREATED THROUGH A SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2227530 UPSYLON MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR APICAL VAGINAL AND UTERINE PROLAP OTO BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention