MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2010-03-18 for APNEA RISK EVALUATION SYSTEM - ARES- UNICORDER 610 manufactured by Advanced Brain Monitoring, Inc..
[18276072]
The patient used a home testing device worn on head one night. This device screens patients at home for sleep apnea. Upon awakening in the morning, the patient reported skin redness on her forehead - rectangular- approximatley one inch and slight bleeding after washing area.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004964738-2010-00001 |
| MDR Report Key | 2728863 |
| Report Source | 04 |
| Date Received | 2010-03-18 |
| Date of Report | 2010-03-15 |
| Date of Event | 2010-02-25 |
| Date Added to Maude | 2012-09-11 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | TIM ZAVORA |
| Manufacturer Street | 2237 FARADAY AVENUE SUITE 100 |
| Manufacturer City | CARLSBAD CA 92008 |
| Manufacturer Country | US |
| Manufacturer Postal | 92008 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | APNEA RISK EVALUATION SYSTEM - ARES- UNICORDER |
| Generic Name | ARES UNICORDER |
| Product Code | MNR |
| Date Received | 2010-03-18 |
| Returned To Mfg | 2010-03-12 |
| Model Number | 610 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ADVANCED BRAIN MONITORING, INC. |
| Manufacturer Address | 9237 FARADAY AVE. STE 100 CARLSBAD CA 92008 US 92008 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2010-03-18 |