ADVANTAGE FIT SYSTEM M0068502110 850-211

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2020-03-27 for ADVANTAGE FIT SYSTEM M0068502110 850-211 manufactured by Boston Scientific Corporation.

MAUDE Entry Details

• Report Number: 3005099803-2020-01319
• MDR Report Key: 9892027
• Report Source: COMPANY REPRESENTATIVE,CONSUM
• Date Received: 2020-03-27
• Date of Report: 2020-03-27
• Date of Event: 2017-03-20
• Date Mfgr Received: 2020-03-02
• Date Added to Maude: 2020-03-27
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: CAROLE MORLEY
• Manufacturer Street: 300 BOSTON SCIENTIFIC WAY
• Manufacturer City: MARLBOROUGH MA 01752
• Manufacturer Country: US
• Manufacturer Postal: 01752
• Manufacturer Phone: 5086834015
• Manufacturer G1: BOSTON SCIENTIFIC CORPORATION
• Manufacturer Street: 780 BROOKSIDE DRIVE
• Manufacturer City: SPENCER IN 47460
• Manufacturer Country: US
• Manufacturer Postal Code: 47460
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ADVANTAGE FIT SYSTEM
• Generic Name: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
• Product Code: OTN
• Date Received: 2020-03-27
• Model Number: M0068502110
• Catalog Number: 850-211
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BOSTON SCIENTIFIC CORPORATION
• Manufacturer Address: 300 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2020-03-27