MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-19 for ARES manufactured by .
[50303756]
I was prescribed a home sleep study by my physician. I was sent to an ares device to wear to collect the data from the study. The following morning, i was left with a large red blistered mark on my forehead and severe headache. The mark on my forehead persisted and i still have a large red scar there from the device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5063596 |
| MDR Report Key | 5815124 |
| Date Received | 2016-07-19 |
| Date of Report | 2016-07-19 |
| Date of Event | 2016-05-17 |
| Date Added to Maude | 2016-07-22 |
| 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 | ARES |
| Generic Name | ARES |
| Product Code | MNR |
| Date Received | 2016-07-19 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-07-19 |