THERATRON T780 G22

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,05,06 report with the FDA on 2000-05-15 for THERATRON T780 G22 manufactured by Mds Nordion.

Event Text Entries

[152384] A report was received that the source failed to automatically return to the fully shielded position.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 8022247-2000-00004
• MDR Report Key: 278282
• Report Source: 00,01,05,06
• Date Received: 2000-05-15
• Date of Report: 2000-05-13
• Date of Event: 2000-05-12
• Date Mfgr Received: 2000-05-13
• Date Added to Maude: 2000-05-22
• 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: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 0
• Manufacturer Contact: E. MARTELL
• Manufacturer Street: 447 MARCH RD.
• Manufacturer City: KANATA, ONTARIO K2K 1X8
• Manufacturer Country: *
• Manufacturer Postal: K2K 1X8
• Manufacturer Phone: 5922790
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: THERATRON
• Generic Name: COBALT TELETHERAPY DEVICE
• Product Code: IWD
• Date Received: 2000-05-15
• Model Number: T780
• Catalog Number: G22
• Lot Number: NA
• ID Number: NA
• Device Availability: Y
• Device Eval'ed by Mfgr: Y
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 269363
• Manufacturer: MDS NORDION
• Manufacturer Address: 447 MARCH ROAD KANATA, ONTARIO * K2K 1X8
• Baseline Brand Name: THERATRON
• Baseline Generic Name: COBALT TELETHERAPY DEVICE
• Baseline Model No: T780
• Baseline Catalog No: G22
• Baseline ID: NA

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2000-05-15