MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-29 for GXS-700 manufactured by Gendex.
[79067363]
Sensor overheated and caused minor burn.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5070773 |
| MDR Report Key | 6684008 |
| Date Received | 2017-06-29 |
| Date of Report | 2017-06-29 |
| Date of Event | 2017-06-26 |
| Date Added to Maude | 2017-07-03 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | GXS-700 |
| Generic Name | INTRAORAL SENSOR |
| Product Code | MUH |
| Date Received | 2017-06-29 |
| Model Number | GXS-700 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GENDEX |
| Manufacturer Address | HATFIELD PA 19440 US 19440 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-06-29 |