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	Abdominal Pain (1685); Micturition Urgency (1871); Hemorrhage/Blood Loss/Bleeding (1888); Pain (1994); Discomfort (2330); Unspecified Mental, Emotional or Behavioural Problem (4430); Dyspareunia (4505); Urinary Incontinence (4572); Insufficient Information (4580)
Date of Event	04/07/2011
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3 date of event: the exact event onset date is unknown.The provided event date of february 11, 2025, was chosen as a best estimate based on the date the manufacturer was made aware of the event.Blocks d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block e1: this event was reported by the patient's legal representation.Block h6: the patient code e2401 captures the reportable event of unspecified injury.The impact code f12 captures the reportable of patient filed for a legal claim related to the unspecified injury related to the implanted mesh.
Event or Problem Description
It was reported that the patient who was implanted with this boston scientific mesh experienced an unspecified injury.Additional details regarding this event were not provided.
Additional Manufacturer Narrative
Block h2: additional information blocks b2, b3, b5, d4, d6a, e1, g1, h4, and h6, has been updated based on the additional received on march 1, 2025.Block b3 date of event: the exact event onset date is unknown.The provided event date of april 7, 2011, was chosen as the best estimate based on the date the device was implanted.Block e1: this event was reported by the patient's legal representation.The implanting surgeon is: dr.(b)(6).Block h6: the patient code e0506 captures the reportable event of internal and vaginal bleeding, the patient code e1002 captures the reportable event of abdominal pain, the patient code e1405 captures the reportable event of pain during sexual intercourse, the patient code e0206 captures the reportable event of emotional distress, the patient code e2330 captures the reportable event of back pain and constant pain, the patient code e2311 captures the reportable event of discomfort.The impact code f1202 captures the reportable of patient is unable to leave the house without difficulty and requires assistance from her family with domestic tasks.
Event or Problem Description
It was reported that the patient implanted with the advantage fit system has experienced several complications, including worsened incontinence, internal and vaginal bleeding, and abdominal and back pain.She has also suffered emotional distress and pain during sexual intercourse, which has led to an inability to engage in sexual activity.The patient also claims to experience constant urinary urgency.Additionally, she suffers from persistent pain, which has affected her mobility and limited her ability to lift objects.Her pain and discomfort are such that she is unable to leave the house without difficulty and requires assistance from her family with domestic tasks.

• 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: 21529674
• Report Number: 2124215-2025-12766
• Device Sequence Number: 15876941
• Product Code: OTN
• UDI-Device Identifier: 08714729772880
• UDI-Public: (01)08714729772880(17)130731(10)1ML0071901
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K020110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2025

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: 07/31/2013
• Device Model Number: M0068502110
• Device Catalogue Number: M0068502110
• Device Lot Number: 1ML0071901
• 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: 02/11/2025
• Supplement Date Received by Manufacturer: 05/01/2025
• Initial Report FDA Received Date: 03/05/2025
• Supplement Report FDA Received Date: 05/19/2025
• Date Device Manufactured: 08/18/2010
• 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; Disability
• Patient Sex: Unknown