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

Model Number	M0068505001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Calcium Deposits/Calcification (1758); Unspecified Infection (1930); Pain (1994); Urinary Tract Infection (2120); Unspecified Mental, Emotional or Behavioural Problem (4430); Unspecified Kidney or Urinary Problem (4503)
Date of Event	12/23/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had an obtryx system implanted during a procedure and has since experienced complications, including recurrent mesh erosions into the urethra with calcification, pelvic and flank pain, worsening urinary issues, recurrent urinary tract and bladder infections, and a loss of enjoyment of life.Additionally, the patient claims that she has suffered or may in the future suffer damages such as physical pain, mental anguish, physical impairment, and medical expenses due to the implantation of the device.
Additional Manufacturer Narrative
Block b3 date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2016, was chosen as a best estimate based on the date of the mesh was implanted.Block d1, d4: based on court documentation, the device involved in the reported event is listed as advantage model: 850-2110; lot: 0000041748.However, the product details provided in the documentation correspond to an obtryx device.The advantage model number cited does not align with the product specifications associated with the obtryx product family.Therefore, the product information used in this report is based solely on the details available in the court documents.Block e1: this event was reported by the patient's legal representation.The implanting physician is: dr.(b)(6).Block h6: the following imdrf patient code capture the reportable event of: e2006 - captures the reportable event of recurrent mesh erosion.E230901 - captures the reportable event of calcification.E2330 - captures the reportable event of pelvic and flank pain.E1311 - captures the reportable event of worsening urinary problems.E1310 - captures the reportable event of recurrent urinary tract and bladder infections.E1906 - captures the reportable event of bladder infections.E0206 - captures the reportable event of mental anguish.The following imdrf impact code capture the reportable event of: f12 - captures the reportable event of the patient had filed a legal claim for an unspecified personal injury related to the device.

• Brand Name: OBTRYX 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: 23018250
• Report Number: 2124215-2025-63181
• Device Sequence Number: 15888137
• Product Code: OTN
• UDI-Device Identifier: 08714729718994
• UDI-Public: (01)08714729718994(17)190831(10)41748
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K040787
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 09/10/2025

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: 08/31/2019
• Device Model Number: M0068505001
• Device Catalogue Number: 850-500
• Device Lot Number: 0000041748
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2025
• Initial Report FDA Received Date: 09/10/2025
• Date Device Manufactured: 08/31/2016
• 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: Female