MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-07 for AICURE AIBREATHE manufactured by Ai Cure Llc.
[144563657]
Hello, i am on a clinical trial for my sickness and they told me to use an app on my phone to tell me what pills to take and when. Now it's been months on this medicine and they told me that the app is telling me to take the wrong medications and i'm still feeling problems. The app is from aicure and it is telling me the wrong thing. Www. Aicure. Com. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086461 |
| MDR Report Key | 8591404 |
| Date Received | 2019-05-07 |
| Date of Report | 2019-04-29 |
| Date of Event | 2019-04-10 |
| Date Added to Maude | 2019-05-08 |
| 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 | AICURE AIBREATHE |
| Generic Name | REMINDER, MEDICATION |
| Product Code | NXQ |
| Date Received | 2019-05-07 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AI CURE LLC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-05-07 |