MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-15 for ARES UNICORDER manufactured by Watermark Medical Inc..
[92456358]
Patient called to report an adverse event involving her ares device. Patient stated that the tubing and cannula pieces were already opened. , and not secure in packaging. Patient said after the first night of use, she woke with a dry throat. Patient said after the second night she woke with a wore throat, and after the third night she woke up sick. Patient stated she has a very sore throat, cold, sinus problems, hurts to swallow, headache, and ears are painful. Patient believes the package was not sanitized properly or not properly handled, which caused her to become sick. Patient believes the device was contaminated with germs.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5073357 |
| MDR Report Key | 7037454 |
| Date Received | 2017-11-15 |
| Date of Report | 2017-11-15 |
| Date of Event | 2017-11-12 |
| Date Added to Maude | 2017-11-16 |
| 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 UNICORDER |
| Generic Name | ARES UNICORDER |
| Product Code | MNR |
| Date Received | 2017-11-15 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WATERMARK MEDICAL INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-11-15 |