MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-13 for ACCUBOOST manufactured by Unk.
[28804943]
Hospital admission (b)(6) 2015 discharged (b)(6) 2015. A (b)(6) female, noted to have numbness and generalized weakness in her right arm. Symptoms resolved within 10-15 minutes. Admitted to ed to be evaluated. Bp at this time 188/106. Pt recalls slurring of speech on the way to the hospital. Pt alert and oriented with normal motor function, no local deficits at time of admission. Consult completed by neurology. His impression symptom related to hypertension, but cannot exclude possibility of tia, so we will treat as tia. Grading of symptoms: hypertension - grade 2 unrelated to accuboost, tia - grade 3 unrelated to accuboost. Pt was treated with accuboost apbi on (b)(6) 2013 through (b)(6) 2013. Total dose 34 gy, 10 fractions.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5057163 |
| MDR Report Key | 5161589 |
| Date Received | 2015-10-13 |
| Date of Report | 2015-10-13 |
| Date of Event | 2015-08-31 |
| Date Added to Maude | 2015-10-20 |
| 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 |
| 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 | ACCUBOOST |
| Generic Name | BREAST BRACHY THERAPY |
| Product Code | JAQ |
| Date Received | 2015-10-13 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2015-10-13 |