MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-16 for ARES APNEA RISK EVALUATION SYSTEM manufactured by Water Mark Medical Inc..
[92523301]
I was sent an ares device that you wear 2 nights to test for sleep apnea. It involved a little machine, with tubing and a belt. I was told to watch this: (b)(6). My machine had add'l tubing and a belt, which was not explained in the video. I used the device and the 1st night i noticed my throat was sore, and the 2nd night it was worse. Well today, day 3 i am very sick. I don't believe the tubing was sanitized correctly. I called the company to complain, and they assured me it was sanitized, but still there is no other reason for me to be ill, except i was getting unsanitary air from the cannula. I returned the device so at this point you would have to contact this company: (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5073391 |
| MDR Report Key | 7040888 |
| Date Received | 2017-11-16 |
| Date of Report | 2017-11-15 |
| Date of Event | 2017-11-13 |
| Date Added to Maude | 2017-11-17 |
| 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 APNEA RISK EVALUATION SYSTEM |
| Generic Name | BREATHING FREQUENCY MONITOR |
| Product Code | BZQ |
| Date Received | 2017-11-16 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WATER MARK MEDICAL INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2017-11-16 |