MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05,06 report with the FDA on 2014-12-16 for MICROSELECTRON MHDR DIGITAL manufactured by Nucletron.
[15321846]
The patient visited the breast surgeon for skin redness, two weeks after a savi applicator breast treatment. The surgeon reviewed the treatment plan and determined that the catheter was reconstructed backwards with the dose heavily weighted toward the connector end of the savi applicator. This results in a dose given at certain proximity to the skin which can cause skin redness. Nucletron did not receive data to determine the severity of the event. The savi applicator was connected to a nucletron microselectron afterloader and the treatment planning was performed with nucletron oncentra brachytherapy treatment planning software.
Patient Sequence No: 1, Text Type: D, B5
[15552861]
The user was consulted on how such a case can be avoided. The user was advised this can be prevented with features available for this in oncentra brachy. No specific details were provided by the user to perform further analysis. No information received from hospital.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9611894-2014-00004 |
| MDR Report Key | 4332511 |
| Report Source | 00,05,06 |
| Date Received | 2014-12-16 |
| Date of Report | 2014-12-16 |
| Date of Event | 2014-11-21 |
| Date Mfgr Received | 2014-11-21 |
| Date Added to Maude | 2014-12-16 |
| 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 | LINAC HOUSE FLEMING WAY |
| Manufacturer City | CRAWLEY, WEST SUSSEX RH109RR |
| Manufacturer Country | UK |
| Manufacturer Postal | RH10 9RR |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MICROSELECTRON MHDR |
| Generic Name | SYSTEM, APPLICATOR, RADIONUCLIDE, REMOTE-CONTROLLED |
| Product Code | JAQ |
| Date Received | 2014-12-16 |
| Model Number | DIGITAL |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NUCLETRON |
| Manufacturer Address | WAARDGELDER 1 VEENENDAAL, NL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-12-16 |