MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-13 for ARES UNICODER ARES610 manufactured by Watermark Medical Inc..
[45501856]
Patient wore home sleep testing device for one night. Reported having trouble with device all night. Stated had headache when she put the device on. Woke up the following morning with red spot on forehead that was sore and was in the middle where the sensor would have sat. The red spot progressively got worse throughout the day eventually blistering and seeping. Manufacturer name: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5062324 |
| MDR Report Key | 5662228 |
| Date Received | 2016-05-13 |
| Date of Report | 2016-05-13 |
| Date of Event | 2016-05-03 |
| Date Added to Maude | 2016-05-18 |
| 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 |
| 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 UNICODER |
| Generic Name | APNEA RISK EVALUATION SYSTEM |
| Product Code | MNR |
| Date Received | 2016-05-13 |
| Returned To Mfg | 2016-05-10 |
| Model Number | ARES610 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WATERMARK MEDICAL INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-05-13 |