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

Model Number	72843
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Calcium Deposits/Calcification (1758); Fistula (1862); Micturition Urgency (1871); Pain (1994); Sepsis (2067); Urinary Tract Infection (2120); Unspecified Mental, Emotional or Behavioural Problem (4430); Dyspareunia (4505); Unspecified Tissue Injury (4559)
Date of Event	03/23/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3 date of event: date of event was approximated to (b)(6) 2022, implant date, as no event date was reported.Block h6: the following imdrf patient codes capture the reportable events of: e2330 - pain.E2006 - erosion.E0306 - sepsis.E1405 - dyspareunia.E2314 - fistula.The following imdrf impact codes capture the reportable events of: f1905 - vaginal mesh removal.F1901 - additional surgery.F23 - unexpected medical intervention.F08 - hospitalization.F1001 - absence of procedure.
Event or Problem Description
It was reported that a polyform synthetic mesh was implanted to the patient on (b)(6) 2022.Following the implantation, the patient sustained severe, painful, and irreversible complications related to the mesh eroding into the bladder and vagina.A 1.3 cm calcified vesicovaginal fistula was first identified during cystoscopy on (b)(6) 2024.On (b)(6) 2024, a partial mesh excision was made but did not resolve the injury.A second surgery on (b)(6) 2025, removed a large mass of calcified mesh; however, the fistula persisted.On (b)(6) 2025, the patient experienced a life-threatening episode of urinary sepsis.A third surgery on (b)(6) 2025, attempted to repair the damage but was unsuccessful due to extensive tissue damage caused by the mesh.On (b)(6) 2025, the patient was hospitalized for five days following another episode of sepsis.The patient was subsequently referred to a specialist in urinary diversion surgery.The procedure was initially scheduled for (b)(6) 2025 but was postponed due to a four-day sepsis episode.On (b)(6) 2025, urinary diversion surgery was performed, involving removal of the bladder and urethra and creation of an indiana pouch.This procedure utilized a segment of the colon to form a continent urinary reservoir, which must be drained via urostomy catheter every four to six hours for the remainder of the patient's life.As a result of these complications, the patient has endured significant pain and suffering, has lost her employment, and has been unable to engage in sexual intercourse for over one year.
Additional Manufacturer Narrative
Block h11: correction to block h6: patient codes.Block b3 date of event: date of event was approximated to (b)(6), 2022, implant date, as no event date was reported.Block h6: the following imdrf patient codes capture the reportable events of: e2330 - pain e2006 - erosion e0306 - sepsis e1405 - dyspareunia e2314 - fistula e1310 - urinary tract infection.The following imdrf impact codes capture the reportable events of: f1905 - vaginal mesh removal f1901 - additional surgery f23 - unexpected medical intervention f08 - hospitalization.F1001 - absence of procedure.
Event or Problem Description
It was reported that a polyform synthetic mesh was implanted to the patient on march 23, 2022.Following the implantation, the patient sustained severe, painful, and irreversible complications mesh erosion into the bladder and vagina.A 1.3 cm calcified vesicovaginal fistula was first identified during cystoscopy on(b)(6) 2024.On (b)(6) 2024, a partial mesh excision was made but did not resolve the injury.A second surgery on (b)(6) 2025, removed a large mass of calcified mesh; however, the fistula persisted.On (b)(6) 2025, the patient experienced a life-threatening episode of urinary sepsis.A third surgery on (b)(6) 2025, attempted to repair the damage but was unsuccessful due to extensive tissue damage caused by the mesh.On (b)(6) 2025, the patient was hospitalized for five days following another episode of sepsis.The patient was subsequently referred to a specialist in urinary diversion surgery.The procedure was initially scheduled for (b)(6), 2025, but was postponed due to a four-day sepsis episode.On (b)(6), 2025, urinary diversion surgery was performed, involving removal of the bladder and urethra and creation of an indiana pouch.This procedure utilized a segment of the colon to form a continent urinary reservoir, which must be drained via urostomy catheter every four to six hours for the remainder of the patient's life.As a result of these complications, the patient has endured significant pain and suffering, has lost her employment, and has been unable to engage in sexual intercourse for over one year.

• Brand Name: POLYFORM SYNTHETIC MESH
• Common Device Name: MESH, SURGICAL, POLYMERIC
• 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: 23865606
• Report Number: 2124215-2025-92348
• Device Sequence Number: 20165783
• Product Code: OTO
• UDI-Device Identifier: 08714729839231
• UDI-Public: (01)08714729839231(17)240930(10)C004323
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K051245
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2026

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: 09/30/2024
• Device Model Number: 72843
• Device Catalogue Number: 72843
• Device Lot Number: C004323
• 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: 12/01/2025
• Supplement Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 02/26/2026
• Date Device Manufactured: 09/11/2021
• 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; Hospitalization; Required Intervention
• Patient Sex: Female