MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-28 for ARES HOME SLEEP TEST 160010553 manufactured by Watermark Medical.
[30379535]
Used the ares home sleep test on the evenings of (b)(6) 2015. On day 2, the device caused enough discomfort to wake me from sleep. There was a burning sensation on my forehead. When removed the device, there was a red welt mark on forehead.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5057591 |
| MDR Report Key | 5196907 |
| Date Received | 2015-10-28 |
| Date of Report | 2015-10-28 |
| Date of Event | 2015-10-28 |
| Date Added to Maude | 2015-11-03 |
| 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 | 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 HOME SLEEP TEST |
| Generic Name | ARES HOME SLEEP TEST |
| Product Code | NPF |
| Date Received | 2015-10-28 |
| Model Number | 160010553 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WATERMARK MEDICAL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-10-28 |