MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-04-22 for ARES UNICORDER manufactured by Watermark Medical.
[5583176]
On (b)(6) 2015, i was given an ares unicorder sleep monitor by (b)(6) to take home for overnight use. I noticed heat in the forehead area, but since i had already returned this unit on (b)(6) 2015 and was told that i must not have used it properly because it was functioning fine, i kept it on through the intense heat. I took a sleep aid to get to sleep because the heat was keeping me awake and woke up to a square shaped burn on my forehead. I returned the unit to the doctor's office in the morning and was told that it was not supposed to get hot, but no other explantion was given. I called the doctor's office regarding this but my call was not returned and the test was not repeated or results given to me. The location of this device is (was) dr. (b)(6) at (b)(6) for confirmation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5042325 |
| MDR Report Key | 4734113 |
| Date Received | 2015-04-22 |
| Date of Report | 2015-04-22 |
| Date of Event | 2015-02-19 |
| Date Added to Maude | 2015-04-29 |
| 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 | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARES UNICORDER |
| Generic Name | ARES UNICORDER |
| Product Code | MNR |
| Date Received | 2015-04-22 |
| Operator | LAY USER/PATIENT |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WATERMARK MEDICAL |
| Manufacturer Address | BOCA RATON FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-04-22 |