MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-12-20 for ARES UNICORDER 2009 manufactured by Watermark Medical.
[2500018]
After using the ares unicorder device (home sleep testing device) for 2 hours the night of (b)(6) 2011 and 7 hours the night of (b)(6) 2011, i noticed that i had a red bump on my forehead. The bump was approx. 1/2 inch in diameter and 1/4 inch in height. The bump was sensitive and somewhat painful, as if my skin had been burned. As of today, 7 days later, the red mark is still visible, but the swelling and sensitivity was gone within 2 days.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5023566 |
| MDR Report Key | 2390148 |
| Date Received | 2011-12-20 |
| Date of Report | 2011-12-20 |
| Date of Event | 2011-12-12 |
| Date Added to Maude | 2011-12-29 |
| 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 | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| 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 | NPF |
| Date Received | 2011-12-20 |
| Returned To Mfg | 2011-12-16 |
| Model Number | 2009 |
| Lot Number | 160001847 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WATERMARK MEDICAL |
| Manufacturer Address | BOCA RATON FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-12-20 |