MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-05-23 for AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM 720342 manufactured by Xoft, A Subsidiary Of Icad Inc..
[15154629]
Physician had difficulty drawing the saline back out of the balloon applicator to the point where intervention was required to remove the balloon while still full of saline. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[15414843]
Reported issue likely due to a component or mfg defect; corrective and preventative action is in progress.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005594788-2013-00003 |
| MDR Report Key | 3145521 |
| Report Source | 05 |
| Date Received | 2013-05-23 |
| Date of Report | 2013-05-23 |
| Date of Event | 2013-04-24 |
| Date Mfgr Received | 2013-04-24 |
| Date Added to Maude | 2013-08-02 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | STEPHEN NAUGLE |
| Manufacturer Street | 101 NICHOLSON LANE |
| Manufacturer City | SAN JOSE CA 95134 |
| Manufacturer Country | US |
| Manufacturer Postal | 95134 |
| Manufacturer Phone | 4084931541 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM |
| Generic Name | BALLOON APPLICATOR |
| Product Code | JAD |
| Date Received | 2013-05-23 |
| Model Number | 720342 |
| Catalog Number | 720342 |
| Lot Number | NI |
| 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, A SUBSIDIARY OF ICAD INC. |
| Manufacturer Address | SAN JOSE CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-05-23 |