MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SOLYX? SIS SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA

Model Number	M0068507000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	06/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Blocks d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete udi and other product specific information.If additional details become available, a supplemental report will be submitted.Block h6: patient code e0402 captures the reportable event of redness, swelling and itching across the body and face within 24 hours, postoperatively.Impact code f23 captures the reportable of unexpected medical intervention.
Event or Problem Description
It was reported that two patients were implanted with solyx? sis system on the same date.Within 24 hours postoperatively, the patients experienced redness, swelling and itching across the body and face, similar to an allergic reaction to antibiotics.The physician is uncertain whether the observed reactions were related to the use of solyx or attributable to another cause.Both patients received medical treatment for the allergic reactions and have fully recovered.Note: this manufacturer report pertains to the first patient implanted with a solyx device.
Event or Problem Description
It was reported that two patients were implanted with solyx? sis system on the same date.Within 24 hours postoperatively, the patients experienced redness, swelling and itching across the body and face, similar to an allergic reaction to antibiotics.The physician is uncertain whether the observed reactions were related to the use of solyx or attributable to another cause.Both patients received medical treatment for the allergic reactions and have fully recovered.Note: this manufacturer report pertains to the first patient implanted with a solyx device.
Additional Manufacturer Narrative
H11: d4 and h4 have been updated based on the additional information received on july 7, 2025.H6: patient code e0402 captures the reportable event of redness, swelling and itching across the body and face within 24 hours, postoperatively.Impact code f23 captures the reportable of unexpected medical intervention.

• Brand Name: SOLYX? SIS SYSTEM
• Common Device Name: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA
• 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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 22511248
• Report Number: 2124215-2025-45514
• Device Sequence Number: 13073121
• Product Code: PAH
• UDI-Device Identifier: 08714729774044
• UDI-Public: (01)08714729774044(17)270218(10)33450940
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K081275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2025

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 Model Number: M0068507000
• Device Catalogue Number: M0068507000
• Device Lot Number: 0033450940
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2025
• Supplement Date Received by Manufacturer: 07/07/2025
• Initial Report FDA Received Date: 07/15/2025
• Supplement Report FDA Received Date: 08/06/2025
• Date Device Manufactured: 02/19/2024
• 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; Required Intervention
• Patient Sex: Unknown