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

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 10/29/2008

Event Type  Injury  

Event Description

Bladder mesh, i have been trying to report my issues with the bladder mesh, but am having such horrible computer software email issues, my personal info has been compromised.Think someone is trying to claim as me.

• Brand Name: MESH
• Type of Device: GYNECOLOGICAL LAPAROSCOPIC KIT - UPSYLON Y MESH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION ; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 7846677
• MDR Text Key: 119382607
• Report Number: MW5079578
• Device Sequence Number: 1
• Product Code: OHD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2018
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention