SUPERDIMENSION SDTNB1000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-09-30 for SUPERDIMENSION SDTNB1000 manufactured by Covidien Lp - Superdimension Inc.

MAUDE Entry Details

• Report Number: 3004962788-2019-00068
• MDR Report Key: 9137913
• Report Source: COMPANY REPRESENTATIVE,HEALTH
• Date Received: 2019-09-30
• Date of Report: 2019-09-30
• Date of Event: 2019-09-06
• Date Mfgr Received: 2019-09-06
• Date Added to Maude: 2019-09-30
• 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
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: AMY BEEMAN
• Manufacturer Street: 161 CHESHIRE LANE SUITE 100
• Manufacturer City: MINNEAPOLIS MN 55441
• Manufacturer Country: US
• Manufacturer Postal: 55441
• Manufacturer Phone: 7632104064
• Manufacturer G1: COVIDIEN LP - SUPERDIMENSION INC
• Manufacturer Street: 161 CHESHIRE LANE, SUITE 100
• Manufacturer City: PLYMOUTH MN 55441
• Manufacturer Country: US
• Manufacturer Postal Code: 55441
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: SUPERDIMENSION
• Generic Name: BRUSH, BIOPSY, BRONCHOSCOPE (NON-RIGID)
• Product Code: BTG
• Date Received: 2019-09-30
• Model Number: SDTNB1000
• Catalog Number: SDTNB1000
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: COVIDIEN LP - SUPERDIMENSION INC
• Manufacturer Address: 161 CHESHIRE LANE, SUITE 100 PLYMOUTH MN 55441 US 55441

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Other	2019-09-30