MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-21 for ZONA PLUS 3.0 manufactured by Zona Health, Inc.
[137314808]
This device requires you to grip it one hand then the other for a 12 minute routine as hard as you can. This device has injured the lower part of the thumb where the thumb is thickest and connects to the hand. Awaiting an appointment with a hand surgeon. The manufacturer recommends using this product for a minimum of 5 days per week-one per day. They say do this for 12 weeks. I did exactly this , i stopped using it (b)(6) 2018. As i write, it is very painful for me to hold a pen or to do simple tasks like unscrewing a jar top. Most times my thumbs hurt when not using them. I asked the manufacturer for my money back and they refused.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5084294 |
| MDR Report Key | 8366460 |
| Date Received | 2019-02-21 |
| Date of Report | 2019-02-10 |
| Date of Event | 2018-12-20 |
| Date Added to Maude | 2019-02-25 |
| 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 | ZONA PLUS 3.0 |
| Generic Name | EXERCISER, POWERED |
| Product Code | BXB |
| Date Received | 2019-02-21 |
| Model Number | ZONA PLUS 3.0 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZONA HEALTH, INC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2019-02-21 |