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

Model Number	M0068502050
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Urinary Tract Infection (2120); Urinary Frequency / Polyuria (2275)
Date of Event	08/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial reporter name and address: the implanting healthcare facility is: (b)(6).Date of event: exact date unknown, event occurred in (b)(6) 2022.Report source: ansm user report (b)(4); submitted to ansm (agence nationale de securite du medicament et des produits de sante) by the patient.(b)(6).
Event or Problem Description
It was reported to boston scientific corporation that an advantage blue system device was implanted in a procedure on (b)(6) 2022, for the treatment of urinary incontinence.On (b)(6) 2022, the patient began to experience vaginal pain and constant urinary tract infection.The patient has been taking antibiotics for four months as prescribed by the physician.Additionally, the patient is unable to travel long distance because she goes to the toilet frequently.She also often wakes up at night to go to the bathroom.The patient claims to be permanently on antibiotics because her uti keeps recurring, but when she tests herself, there are no results.

• Brand Name: ADVANTAGE 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16294642
• Report Number: 3005099803-2023-00309
• Device Sequence Number: 7492851
• Product Code: OTN
• UDI-Device Identifier: 08714729961918
• UDI-Public: 08714729961918
• 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,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/03/2023

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: 09/29/2024
• Device Model Number: M0068502050
• Device Catalogue Number: 73184
• Device Lot Number: 0028116610
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2023
• Initial Report FDA Received Date: 02/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female