MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-04-01 for AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM 720342 manufactured by Xoft, A Subsidiary Of Icad.
[3321535]
Balloon applicator popped while in pt; necessitating replacement.
Patient Sequence No: 1, Text Type: D, B5
[10656097]
Evaluation summary: failure likely due to manufacturing defect; corrective and preventive action is in progress.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005594788-2013-00002 |
| MDR Report Key | 3038114 |
| Report Source | 05 |
| Date Received | 2013-04-01 |
| Date of Report | 2013-04-01 |
| Date of Event | 2013-03-01 |
| Date Mfgr Received | 2013-03-05 |
| Device Manufacturer Date | 2013-02-01 |
| Date Added to Maude | 2013-05-30 |
| 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 | BONNIE MCINERNEY |
| Manufacturer Street | 101 NICHOLOSON 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 | 2013-04-01 |
| Model Number | 720342 |
| Catalog Number | 720342 |
| Lot Number | 820759 |
| Device Expiration Date | 2013-02-28 |
| 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, A SUBSIDIARY OF ICAD |
| Manufacturer Address | SAN JOSE CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-04-01 |