MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-03 for SAVI BREAST BRACHYTHERAPY APPLICATOR manufactured by Cianna Medical.
[88140497]
Pt with a history of breast cancer, reports symptoms after using the savi radiation therapy. She reports using the therapy for 5 days at 2 sessions per day as instructed. Pt noticed her breast looking "butchered" and decided to go to the er. Her right breast was bleeding, throbbing, and very painful. Tests done in the lab showed severe infection. Other symptoms include fatigue, nausea, swelling, suppressed immune system and not being able to sleep. Her medications and creams have not relieved her from any pain. The reporter also states her personal oncologist did not recommend this type of surgery since she is not a candidate for it.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5072569 |
| MDR Report Key | 6910892 |
| Date Received | 2017-10-03 |
| Date of Report | 2017-10-02 |
| Date of Event | 2017-08-13 |
| Date Added to Maude | 2017-10-03 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| 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 | 0 |
| Brand Name | SAVI BREAST BRACHYTHERAPY APPLICATOR |
| Generic Name | SYSTEM, APPLICATOR, RADIONUCLIDE, REMOTE-CONTROL |
| Product Code | JAQ |
| Date Received | 2017-10-03 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CIANNA MEDICAL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-10-03 |