OtherIXI
AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM
Received May 23, 2012 · Event occurred Apr 26, 2012
Report 3005594788-2012-00001 · MDR key 2593902
Device
Generic name
Balloon Appplicator
Manufacturer
Xoft, Inc.Model number
AT2056Catalog number
AT2056
Lot number
820539
Product problems
- Hole In Material
Patient
NI
- No Information
Narrative
Additional Manufacturer Narrative
EVALUATION SUMMARY: HOLE WAS CONFIRMED.
Description of Event or Problem
THE AXXENT EBX BALLOON APPLICATOR SHAFT HAD A HOLE IN IT. (B)(4).
Remedial action
- Relabeling