MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-04 for AXXENT manufactured by Xoft, A Subsidiary Of Icad.
[30403363]
Patient Sequence No: 1, Text Type: N, H10
[30403364]
Before inserting an iort (intraoperative radiation therapy) balloon, asymmetry was detected. Staff also felt the instillation of saline was not quite right. The asymmetric balloon was replaced by a new balloon.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5200434 |
| MDR Report Key | 5200434 |
| Date Received | 2015-11-04 |
| Date of Report | 2015-10-16 |
| Date of Event | 2015-10-14 |
| Report Date | 2015-10-16 |
| Date Reported to FDA | 2015-10-16 |
| Date Reported to Mfgr | 2015-10-16 |
| Date Added to Maude | 2015-11-04 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AXXENT |
| Generic Name | SYSTEM, THERAPEUTIC, X-RAY |
| Product Code | JAD |
| Date Received | 2015-11-04 |
| Device Expiration Date | 2016-08-15 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | XOFT, A SUBSIDIARY OF ICAD |
| Manufacturer Address | 101 NICHOLSON LN SANJOSE CA 95134 US 95134 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-11-04 |