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	Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943)
Date of Event	07/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: device code e0402 captures the reportable event of allergic reaction.
Event or Problem Description
It was reported that an advantage fit blue was implanted to the patient during a procedure performed on (b)(6) 2025.Following the implantation, the patient has experienced persistent itching which has improved over time but still persists.While attempting to identify the cause, the patient disclosed an allergy to cobalt blue, prompting the physician to inquire about the dye used in the mesh.The physician noted that the patient may also have an allergy to copper and further evaluation was directed.The patient has been scheduled to undergo allergy skin testing in (b)(6) 2025.
Additional Manufacturer Narrative
Block h11: blocks b2, b5, and h6 have been updated based on the additional information received on december 23, 2025.Block h6: device code e0402 captures the reportable event of allergic reaction.
Event or Problem Description
It was reported that an advantage fit blue was implanted to the patient during a procedure performed on (b)(6) 2025.Approximately two weeks following the implantation, the patient has experienced persistent itching which has improved over time but still persists.Aside from chronic itching, no additional symptoms were reported, and the patient's current condition is otherwise normal.While attempting to identify the cause, the patient disclosed an allergy to cobalt blue, prompting the physician to inquire about the dye used in the mesh.The physician noted that the patient may also have an allergy to copper and further evaluation was directed.The patient has been scheduled to undergo allergy skin testing in (b)(6) 2025.In the physician's opinion, it is currently uncertain whether the device or procedure contributed to the patient's symptoms, pending the results of allergy testing.To date, management has included medical treatment for chronic itching and treatment for scabies, with allergy patch testing identified as the next step in evaluation.

• 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: 23787019
• Report Number: 2124215-2025-90542
• Device Sequence Number: 10442835
• Product Code: OTN
• UDI-Device Identifier: 08714729961925
• UDI-Public: (01)08714729961925(17)280521(10)36583162
• 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
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2026

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 Model Number: M0068502120
• Device Catalogue Number: M0068502120
• Device Lot Number: 0036583162
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2025
• Supplement Date Received by Manufacturer: 12/23/2025
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 01/15/2026
• Date Device Manufactured: 05/22/2025
• 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; Required Intervention
• Patient Sex: Female