MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION UPSYLON MESH IMPLANT; MESH, SURGICAL SYNTHETIC UROGYNECOLOGIC FOR APICAL VAGINAL AND UTERINE PROLAPSE,

Device Problems Break (1069); Collapse (1099)

Patient Problem Obstruction/Occlusion (2422)

Event Date 03/15/2019

Event Type  Injury  

Event Description

Had to have surgery to remove broken mesh implant and repair blockage in my bladder due to the mesh implant.The implant was put in on (b)(6) 2018 for a partial hysterectomy due to a uterine prolapse.A second surgery was then performed on (b)(6) 2018 to repair / revision due to the mesh collapsing.Fda safety report id# (b)(4).

• Brand Name: UPSYLON MESH IMPLANT
• Type of Device: MESH, SURGICAL SYNTHETIC UROGYNECOLOGIC FOR APICAL VAGINAL AND UTERINE PROLAPSE,
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 8591205
• MDR Text Key: 144529233
• Report Number: MW5086450
• Device Sequence Number: 1
• Product Code: OTO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/04/2019
• 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?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/07/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization