FDA.reportPublic FDA data

MAUDE MDR 2096919

MDR report key
2096919
Report number
3005594788-2011-00020
Event key
0
Event type
3
Date of event
2011-04-21
Date received
2011-04-29
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
STEVE LIN
Address
345 POTRERO AVE. SUNNYVALE CA 94085 US
Phone
408-408-4084
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1AXXENT FLEXISHIELD MINIBEAM BLOCKS FOR RADIATION THERAPYXOFT, INC.IXIF5300F5300R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-04-290

Event Narratives#

N

Patient 1

DURING (B)(6) FOLLOW-UP 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 PATIENT INJURY. COMPANY IS COLLECTING FURTHER INFORMATION TO ASCERTAIN THIS EVENT. THIS MDR IS RELATED TO MDR 3005594788-2011-00001.

D

Patient 1

DURING (B)(6) FOLLOW-UP FOR INTRA-OPERATIVE RADIATION TREATMENT OF THE BREAST, THE MAMMOGRAM SHOWED POWDERY MATERIAL ON AND NEAR THE TREATMENT SITE. INCIDENT DID NOT RESULT IN PATIENT INJURY.