MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-05-23 for AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM AT2056 manufactured by Xoft, Inc..
[20955377]
The axxent ebx balloon applicator shaft had a hole in it. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[21149302]
Evaluation summary: hole was confirmed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005594788-2012-00001 |
| MDR Report Key | 2593902 |
| Report Source | 05 |
| Date Received | 2012-05-23 |
| Date of Report | 2012-05-22 |
| Date of Event | 2012-04-26 |
| Date Mfgr Received | 2012-04-26 |
| Device Manufacturer Date | 2011-07-01 |
| Date Added to Maude | 2012-08-03 |
| 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 Street | 345 POTRERO AVE. |
| Manufacturer City | SUNNYVALE CA 94085 |
| Manufacturer Country | US |
| Manufacturer Postal | 94085 |
| Manufacturer Phone | 4084192341 |
| Single Use | 3 |
| Remedial Action | RB |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM |
| Generic Name | BALLOON APPPLICATOR |
| Product Code | IXI |
| Date Received | 2012-05-23 |
| Returned To Mfg | 2012-04-30 |
| Model Number | AT2056 |
| Catalog Number | AT2056 |
| Lot Number | 820539 |
| Device Expiration Date | 2013-07-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | XOFT, INC. |
| Manufacturer Address | SUNNYVALE CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-05-23 |