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	Adhesion(s) (1695); Pain (1994); Scar Tissue (2060); Hernia (2240); Obstruction/Occlusion (2422); Unspecified Mental, Emotional or Behavioural Problem (4430); Dyspareunia (4505)
Date of Event	12/10/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Note: this manufacturer report pertains to the second of two devices used during the same procedure.Please refer to manufacturer report 2124215-2025-54036 for the associated device.It was reported that the patient had both a lynx blue system and upsylony-mesh system devices implanted during a procedure and has since experienced complications.These include small bowel obstruction, internal hernia, adhesions, scarring, pain including dyspareunia, and a loss of enjoyment of life.Additionally, the patient claims to have suffered, or may suffer in the future 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 december 10, 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.The implanting physician is: dr.(b)(6).(b)(6) medical center.(b)(6) united states.Block h6: the imdrf patient codes capture the reportable events of: e2328 - captures the reportable event of small bowel obstruction.E2319 - captures the reportable event of internal hernia.E2101 - captures the reportable event of adhesions.E1715 - captures the reportable event of scarring.E2330 - captures the reportable event of pain.E1405 - captures the reportable event of dyspareunia.E0206 - captures the reportable event of mental pain and loss of enjoyment of life.The imdrf impact code capture the reportable event of: f12 - captures the reportable event of patient had filed a legal claim for an unspecified personal injury related to 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: 22747094
• Report Number: 2124215-2025-54043
• Device Sequence Number: 9122394
• Product Code: OTO
• UDI-Device Identifier: 08714729839217
• UDI-Public: (01)08714729839217(17)240731(10)C004271
• 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
• 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): 08/08/2025

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: 07/31/2024
• Device Model Number: M0068318200
• Device Catalogue Number: 831-820
• Device Lot Number: C004271
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 08/08/2025
• Date Device Manufactured: 07/03/2021
• 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: Other
• Patient Sex: Female