MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-01-17 for AXXENT FLEXISHIELD MINI F5300 manufactured by Xoft, Inc..
[18205793]
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 pt 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
[18226746]
During six month 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 pt injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005594788-2011-00003 |
| MDR Report Key | 1994861 |
| Report Source | 05,06 |
| Date Received | 2011-01-17 |
| Date of Report | 2011-01-17 |
| Date of Event | 2011-01-10 |
| Date Mfgr Received | 2011-01-10 |
| Date Added to Maude | 2011-03-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | STEVE LIN |
| Manufacturer Street | 345 POTRERO AVE. |
| Manufacturer City | SUNNYVALE CA 94085 |
| Manufacturer Country | US |
| Manufacturer Postal | 94085 |
| Manufacturer Phone | 4084192341 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AXXENT FLEXISHIELD MINI |
| Generic Name | BEAM BLOCKS FOR RADIATION THERAPY |
| Product Code | IXI |
| Date Received | 2011-01-17 |
| Model Number | F5300 |
| Catalog Number | F5300 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | XOFT, INC. |
| Manufacturer Address | 345 POTRERO AVE SUNNYVALE CA 94085 US 94085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-01-17 |