MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ADVANTAGE FIT? BLUE SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

Model Number	M0068502120
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Urinary Tract Infection (2120); Deformity/ Disfigurement (2360); Unspecified Mental, Emotional or Behavioural Problem (4430); Unspecified Kidney or Urinary Problem (4503); Dyspareunia (4505); Unspecified Tissue Injury (4559)
Date of Event	08/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was implanted with an advantage fit system and has since experienced numerous injuries, including, but not limited to chronic pelvic pain, recurrent urinary tract infections, voiding dysfunction, pelvic floor dysfunction, vaginal and urethral atrophy, and pain during intercourse.Subsequently, she underwent a revision surgery on (b)(6) 2023, and a partial excision on (b)(6) 2023.Despite this, the patient has suffered significant pain, disfigurement, embarrassment, and unnecessary expense.She may require additional surgery and long-term medical treatment.The patient has sustained and is expected to continue sustaining severe and debilitating injuries, serious bodily harm, and mental and physical pain and suffering, along with ongoing economic losses that may persist far into the future.
Additional Manufacturer Narrative
Block b3: the exact event onset date is unknown.The provided event date of(b)(6) 2023 was chosen as a best estimate based on the date of the first revision surgery.Block e1: this event was reported by the patient's legal representation.The surgeons are: implanting and revision surgeon (b)(6) 2023): (b)(6) 2023): (b)(6) oh block h6: the following imdrf patient codes capture the reportable events below: e2330 - pain e1310 - recurrent urinary tract infections e2015 - atrophy e1405 - dyspareunia e2308 - disfigurement imdrf impact code f1905 captures the reportable event of mesh revision and partial excision surgeries.

• Brand Name: ADVANTAGE FIT? BLUE SYSTEM
• Common Device Name: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 22366476
• Report Number: 2124215-2025-42923
• Device Sequence Number: 9582748
• Product Code: OTN
• UDI-Device Identifier: 08714729961925
• UDI-Public: (01)08714729961925(17)260417(10)31447745
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K020110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/17/2026
• Device Model Number: M0068502120
• Device Catalogue Number: M0068502120
• Device Lot Number: 0031447745
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2024
• Initial Report FDA Received Date: 06/30/2025
• Date Device Manufactured: 04/18/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female