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

Model Number	M0068502110
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Urinary Tract Infection (2120); Unspecified Kidney or Urinary Problem (4503)
Date of Event	01/02/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: patient code e1310 captures the reportable event of recurrent urinary tract infections.
Event or Problem Description
It was reported that an advantage fit sling was implanted in the patient.On (b)(6) 2018, the patient returned to the same surgeon for division of the suburethral sling due to voiding dysfunction.At that time, the patient was evaluated for recurrent urinary tract infections, with concern for possible mesh involvement in the bladder.
Additional Manufacturer Narrative
Block h11: correction to blocks b2: outcomes attrib to adv event and h6: patient code.Block h6: the following imdrf patient codes capture the reportable events of e1310 - recurrent urinary tract infections.E2006 - possible mesh involvement in the bladder.
Event or Problem Description
It was reported that an advantage fit sling was implanted in the patient.On (b)(6) 2018, the patient returned to the same surgeon for division of the suburethral sling due to voiding dysfunction.At that time, the patient was evaluated for recurrent urinary tract infections, with concern for possible mesh involvement in the bladder.

• Brand Name: ADVANTAGE FIT 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): FREUDENBERG MEDICAL MIS INC; 2301 centennial boulevard; jeffersonville IN 47130
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 24070314
• Report Number: 2124215-2026-02524
• Device Sequence Number: 10282440
• Product Code: OTN
• UDI-Device Identifier: 08714729772880
• UDI-Public: (01)08714729772880(17)190729(10)38500
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K020110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2026

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: 07/29/2019
• Device Model Number: M0068502110
• Device Catalogue Number: M0068502110
• Device Lot Number: 0000038500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 01/14/2026
• Supplement Report FDA Received Date: 02/25/2026
• Date Device Manufactured: 07/29/2016
• 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: Other
• Patient Sex: Unknown