MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION UPSYLON; MESH, SURGICAL, SYNTHETIC

Model Number	M0068318200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Hemorrhage/Blood Loss/Bleeding (1888); Pain (1994); Scar Tissue (2060); Deformity/ Disfigurement (2360); Unspecified Mental, Emotional or Behavioural Problem (4430); Urinary Incontinence (4572); Insufficient Information (4580)
Date of Event	05/07/2021
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 may 7, 2021, was chosen as a best estimate based on the date of the mesh was implanted.Block e1: this event was reported by the patient's legal representation.(b)(6).Block h6: the imdrf patient codes capture the reportable events of: e2006 - captures the reportable event of mesh erosion.E0506 - captures the reportable event of post-coital bleeding.E2330 - captures the reportable event of pelvic pain.E1715 - captures the reportable event of granulation tissue.E2308 - captures the reportable event of disfigurement.E0206 - captures the reportable event of mental pain and loss of enjoyment of life.E2401 - captures the reportable event of severe and debilitating injuries.The imdrf impact code capture the reportable event of: f1905 - captures the reportable event of mesh revision surgery.F1903 - captures the reportable event of mesh removal surgery.
Event or Problem Description
It was reported that the patient had an upsylon y-mesh implanted during a procedure and has since experienced complications.These include mixed urinary incontinence, erosion of the implanted mesh into surrounding tissues and organs, granulation tissue, post-coital bleeding, and pelvic pain.Subsequently, the patient underwent a partial vaginal mesh excision surgery on (b)(6) 2024, followed by another mesh excision surgery on (b)(6) 2024.The patient also claimed to have suffered severe pain, unnecessary expenses, embarrassment, disfigurement, and harm as a result of the implantation.Additionally, she stated that she may need to undergo further surgery and could, in the future, experience damages such as significant pain, severe and debilitating injuries, serious bodily harm, mental and physical pain and suffering, and ongoing medical expenses due to the implantation of the device.

• Brand Name: UPSYLON
• Common Device Name: MESH, SURGICAL, SYNTHETIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): PROXY BIOMEDICAL LIMITED; coilleach spiddal; galway H91 C 2NF; EI H91 C2NF
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 22815928
• Report Number: 2124215-2025-56831
• Device Sequence Number: 8703876
• Product Code: OTO
• UDI-Device Identifier: 08714729839217
• UDI-Public: (01)08714729839217(17)240331(10)C004229
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K122794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• 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): 08/15/2025

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: 03/31/2024
• Device Model Number: M0068318200
• Device Catalogue Number: 831-820
• Device Lot Number: C004229
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2025
• Initial Report FDA Received Date: 08/15/2025
• Date Device Manufactured: 03/13/2021
• 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: Required Intervention
• Patient Sex: Female