MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-04-29 for AXXENT FLEXISHIELD MINI F5300 manufactured by Xoft, Inc..
[20391570]
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.
Patient Sequence No: 1, Text Type: N, H10
[20411564]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005594788-2011-00020 |
| MDR Report Key | 2096919 |
| Report Source | 05,06 |
| Date Received | 2011-04-29 |
| Date of Report | 2011-04-27 |
| Date of Event | 2011-04-21 |
| Date Mfgr Received | 2011-04-25 |
| Date Added to Maude | 2011-07-22 |
| 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 | RC |
| 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 | 2011-04-29 |
| 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 | 2011-04-29 |