MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION BOSTON SCIENTIFIC UPSYLON MESH; GYNECOLOGICAL LAPAROSCOPIC KIT - UPSYLON

Device Problem Material Erosion (1214)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994)

Event Date 12/11/2018

Event Type  Injury  

Event Description

In (b)(6) 2017 had pop surgery and sling.Began with pain, bleeding, uti until (b)(6) 2018 when i had surgery to remove mesh that eroded through bladder and vagina.Very difficult and painful surgery.Had stent in ureter and supra pubic catheter for a month.Now i'm so disgusted that since mesh was placed trans abdominally, i have no legal recourse immediately available to me.Mesh erosion - bladder/vagina.Fda safety report id# (b)(4).

• Brand Name: BOSTON SCIENTIFIC UPSYLON MESH
• Type of Device: GYNECOLOGICAL LAPAROSCOPIC KIT - UPSYLON
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 8623694
• MDR Text Key: 145541800
• Report Number: MW5086716
• Device Sequence Number: 1
• Product Code: OHD
• 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: 05/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 54 YR
• Patient Weight: 70