AXXENT FLEXISHIELD MINI
Received Jul 8, 2011 · Event occurred Jun 22, 2011
Report 3005594788-2011-00027 · MDR key 2183823
Device
Generic name
Beam Blocks For Radiation Therapy
Manufacturer
Xoft, Inc.Model number
F5300Catalog number
F5300
Product problems
- Nonstandard Device
- Device Contamination with Chemical or Other Material
Patient
62 YR
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
DURING SIX MONTH F/U FOR INTRA-OPERATIVE RADIATION TREATMENT OF THE BREAST, THE MAMMOGRAM SHOWED POWDERY MATERIAL ON AND NEAR THE TREATMENT SITE. INCIDENT DID NOT RESULT IN A PT INJURY.
Additional Manufacturer Narrative
DURING SIX MONTH F/U FOR INTRA-OPERATIVE RADIATION TREATMENT OF THE BREAST, THE MAMMOGRAM SHOWED POWDERY MATERIAL ON AND NEAR THE TREATMENT SITE. DEVICE HAS NOT BEEN RETURNED. INCIDENT DID NOT RESULT IN A PT INJURY. COMPANY IS COLLECTING FURTHER INFO TO ASCERTAIN THIS EVENT. THIS MDR IS RELATED TO MDR 3005594788-2011-00001.
Remedial action
- Recall