MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CONSERVIA; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

Model Number	M0068502210
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Movement Disorder (4412)
Date of Event	06/14/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that several months ago, the patient had pain in the right side of the vaginal, extreme groin pain, and pinching sensation that prevented her from walking.The patient still experienced extreme groin pain and walking problems.It was noted that the patient was looking into removing the device.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event, as no event date was reported.Blocks d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block e1: this complaint was reported by the patient.Block h6: patient code e2330 was used to capture the reportable event of extreme groin pain and pain in the right side of the vaginal.
Additional Manufacturer Narrative
Block b3: date of event was approximated to (b)(6) 2019, implant date, as no event date was reported.Blocks d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block e1: this complaint was reported by the patient.Block h6: patient code e2330 was used to capture the reportable event of extreme groin pain and pain in the right side of the vaginal.Block h11: block d6a updated.
Event or Problem Description
It was reported that several months ago, the patient had pain in the right side of the vaginal, extreme groin pain, and pinching sensation that prevented her from walking.The patient still experienced extreme groin pain and walking problems.It was noted that the patient was looking into removing the device.

• Brand Name: CONSERVIA
• 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: 20528579
• Report Number: 2124215-2024-66793
• Device Sequence Number: 7983711
• Product Code: OTN
• UDI-Device Identifier: 08714729855996
• UDI-Public: 08714729855996
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K020110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2025

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: M0068502210
• Device Catalogue Number: 73226
• 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: 10/08/2024
• Supplement Date Received by Manufacturer: 01/31/2025
• Initial Report FDA Received Date: 10/24/2024
• Supplement Report FDA Received Date: 02/13/2025
• 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