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

Model Number	M0068502120
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Infection (1930); Pain (1994); Abnormal Vaginal Discharge (2123)
Date of Event	09/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an uphold vaginal support system device was implanted during a procedure performed on (b)(6) 2021.Due to the implantation, the patient experienced injuries including pain, severe infections, mesh erosion, bleeding and discharge.She also underwent additional medical treatment and procedures including removal.
Additional Manufacturer Narrative
Block h6: imdrf patient codes e2330, e1401, e2006 and e1906 capture the reported events of pain, discharge, mesh erosion, and severe infection, respectively.Imdrf impact code f23 and f1905 capture the reported event of additional medical treatment and mesh removal.
Additional Manufacturer Narrative
Block h2: correction block g3 (date received by manufacturer) has been updated to the correct manufacturer awareness date for this event, march 11, 2024.Block h6: imdrf patient codes e2330, e1401, e2006 and e1906 capture the reported events of pain, discharge, mesh erosion, and severe infection, respectively.Imdrf impact code f23 and f1905 capture the reported event of additional medical treatment and mesh removal.
Event or Problem Description
It was reported that an uphold vaginal support system device was implanted during a procedure performed on (b)(6) 2021.Due to the implantation, the patient experienced injuries including pain, severe infections, mesh erosion, bleeding and discharge.She also underwent additional medical treatment and procedures including removal.
Event or Problem Description
It was reported that an advantage fit system device was implanted during a procedure performed on (b)(6) 2021.Due to the implantation, the patient experienced injuries including pain, severe infections, mesh erosion, bleeding, and discharge.She also underwent additional medical treatment and procedures including removal.
Additional Manufacturer Narrative
D1, d2a, d2b, d4:model number, catalog number, expiration date, unique identifier (udi) #, g1:mfr site facility name, mfr site address 1, mfr site city, mfr site zip/post code and h11 have been updated based on the additional information received on 23may2024.Block h6: imdrf patient codes e2330 captures the reportable event of pain.Imdrf patient codes e2006 captures the reportable event of erosion.Imdrf patient codes e1401 captures the reportable event of discharge.Imdrf patient codes e1906 captures the reportable event of severe infection.Imdrf impact code f23 captures the reportable event of additional medical treatment.Imdrf impact code f1905 captures the reportable event of mesh removal.

• Brand Name: ADVANTAGE FIT BLUE 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): 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: 19057756
• Report Number: 2124215-2024-18193
• Device Sequence Number: 6140937
• Product Code: OTN
• UDI-Device Identifier: 08714729961925
• UDI-Public: 08714729961925
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K020110
• 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,Followup,Followup
• Report Date (Section B): 06/19/2024
• 2 Devices were Involved in the Event: 1 2

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: 05/31/2024
• Device Model Number: M0068502120
• Device Catalogue Number: 850-212
• Device Lot Number: 0027416039
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/08/2024
• Supplement Date Received by Manufacturer: 03/11/2024; 05/23/2024
• Initial Report FDA Received Date: 04/08/2024
• Supplement Report FDA Received Date: 04/10/2024; 06/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2021
• 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