MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-16 for SENSUS SRT-100 manufactured by Sensus Healthcare Llc.
[45616608]
Had 18 sensus srt-100 treatments on right lower leg for squamous cell skin cancer. I questioned provider about how often equipment was calibrated and checked, assured it was safe. Complained about tenderness, etc, told it was slight "nerve damage" and would be tender then delayed serious radiation burn appeared, requiring 5 months wound care treatment. Extensive hbo involving 6/7 various physicians. Caused lymphedema requiring compression stockings and use of compression sleeves daily. Personal costs and time, i did document the entire 5 months with photos and a log. Wound is healed but have been told, it could reopen. There is a 4 inches area that's pink and may never return to natural skin color again.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5062365 |
| MDR Report Key | 5665965 |
| Date Received | 2016-05-16 |
| Date of Report | 2016-05-16 |
| Date Added to Maude | 2016-05-19 |
| 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 | SENSUS SRT-100 |
| Generic Name | SENSUS SRT-100 |
| Product Code | JAD |
| Date Received | 2016-05-16 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SENSUS HEALTHCARE LLC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-05-16 |