BETA - CATH UNIT *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-10-17 for BETA - CATH UNIT * manufactured by *.

Event Text Entries

[303934] Md felt catheter needed to be repositioned slightly & sources returned to the beta-cath applicator. Sources were not returned within 5 seconds. Md had repositioned catheter & the sources were returned to the stent & irradiation of the vessels was completed w/difficulty. Full assessment of catheter made by appropriate personnel to determine cause of dysfunction. Procedure completed w/o difficulty & no excessive exposure to pt or staff.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1029890
• MDR Report Key: 492833
• Date Received: 2003-10-17
• Date of Report: 2003-10-17
• Date of Event: 2003-09-18
• Date Added to Maude: 2003-11-03
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: BETA - CATH UNIT
• Generic Name: BRACHYTHERAPY CATHETER
• Product Code: MOU
• Date Received: 2003-10-17
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: *
• Implant Flag: Y
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 481533
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2003-10-17