MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-07-31 for HEALTHVANA manufactured by Healthvana.
[23558029]
Potential harm to users - the product is "healthvana". Producer claims "healthvana is the type of advance that captures the opportunity of the individual's need for timely info, in this case sexual health info. Such info may lead to a healthier and even more importantly, more honest successful sexual encounter". This product creates a false sense of safety by providing pre-sexual encounter health info related to the participants. It fails to clearly convey that infectious people may not be revealed in lab results for some time after they become infectious. "timely info" is a misnomer and can lead users to make misguided decisions. The product preys on user's naive trust in technology and puts users at risk.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5045115 |
| MDR Report Key | 4974690 |
| Date Received | 2015-07-31 |
| Date of Report | 2015-07-31 |
| Date of Event | 2015-07-31 |
| Date Added to Maude | 2015-08-05 |
| 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 | HEALTHVANA |
| Generic Name | PT INTAKE, RESULTS DELIVERY, REMINDERS AND ADHERENCE |
| Product Code | NSX |
| Date Received | 2015-07-31 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HEALTHVANA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-31 |