AXXENT FLEXISHIELD MINI F5300

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-02-15 for AXXENT FLEXISHIELD MINI F5300 manufactured by Xoft, Inc..

Event Text Entries

[1892372] During six months 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 a patient injury.
Patient Sequence No: 1, Text Type: D, B5


[9222664] During six month 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 a patient injury. Company is collecting further information to ascertain this event. This mdr is related to mdr 3005594788-2011-00001.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3005594788-2011-00011
MDR Report Key2037663
Report Source05,06
Date Received2011-02-15
Date of Report2011-02-15
Date of Event2011-02-07
Date Mfgr Received2011-02-08
Date Added to Maude2011-07-07
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer Street345 POTRERO AVE
Manufacturer CitySUNNYVALE CA 94085
Manufacturer CountryUS
Manufacturer Postal94085
Manufacturer Phone4084192341
Single Use3
Remedial ActionRC
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameAXXENT FLEXISHIELD MINI
Generic NameBEAM BLOCKS FOR RADIATION THERAPY
Product CodeIXI
Date Received2011-02-15
Model NumberF5300
Catalog NumberF5300
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerXOFT, INC.
Manufacturer Address345 POTRERO AVE SUNNYVALE CA 94085 US 94085


Patients

Patient NumberTreatmentOutcomeDate
10 2011-02-15

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