MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-02-15 for SENSUS HEALTHCARE SRT-100 manufactured by Sensus Healthcare.
[67508303]
The srt-100 system used to deliver therapy operated within its normal design parameters. No issues associated with this system have been noted during the initial review manufacturing testing, inspection, installation, and servicing records.
Patient Sequence No: 1, Text Type: N, H10
[67508304]
Wound/sore at treatment site (application of superficial radiotherapy for the treatment of squamous cell carcinoma). Sensus healthcare received a call from user facility during the first week in september stating that a patient returned after completing treatment for a squamous cell carcinoma (scc) on her dorsal hand with breakdown to the area. Provider stated the patient was wearing work gloves everyday post treatment and wondered if this could be the cause of the breakdown. We discussed how the biologic responses continue on for several weeks and how wearing the gloves may have contributed to the breakdown. Shortly after sensus healthcare received a phone call from physician explaining that the patient did not return with breakdown, that the patient returned due to re-occurrence in the same area. The question asked was; "could this patient's re-occurrence be caused by wearing gloves throughout and post treatment? Sensus healthcare requested the patient's pathology report, fraction log and photos for further evaluation. Note: provider confirmed that the lesion was decreasing in size while under treatment and the patient tolerated the treatment well.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008513398-2016-00002 |
| MDR Report Key | 6332866 |
| Report Source | USER FACILITY |
| Date Received | 2017-02-15 |
| Date of Report | 2016-10-03 |
| Date of Event | 2016-09-07 |
| Date Mfgr Received | 2016-09-15 |
| Device Manufacturer Date | 2012-07-10 |
| Date Added to Maude | 2017-02-15 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. KAL FISHMAN |
| Manufacturer Street | 851 BROKEN SOUND PARKWAY NW #215 |
| Manufacturer City | BOCA RATON FL 33487 |
| Manufacturer Country | US |
| Manufacturer Postal | 33487 |
| Manufacturer Phone | 5619225808 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SENSUS HEALTHCARE SRT-100 |
| Generic Name | SYSTEM, THERAPEUTIC, X-RAY |
| Product Code | JAD |
| Date Received | 2017-02-15 |
| Model Number | SRT-100 |
| Catalog Number | SRT-100 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SENSUS HEALTHCARE |
| Manufacturer Address | 851 BROKEN SOUND PARKWAY NW #215 BOCA RATON FL 33487 US 33487 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-02-15 |