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 |