MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2013-03-25 for ZONA PLUS ZONA PLUS V2 manufactured by Zona Health.
[3260218]
A consumer initially contacted the company on (b)(6) 2013 requesting a refund for his zona plus device. He stated that he would not be needing the device anymore because he had experienced a heart attack. Additional follow-up with the customer on (b)(4) 2013 showed that the customer had been using the device for about 2 months, and had been using it a minimum of 5 days per week as per the instructions for use. He stopped using the device on (b)(6) 2013 on the advice of his physician after experiencing a heart attack. He had never told his physician he was using it until the day of the heart attack and had not experiencing any symptoms of the heart attack until the day of the attack. He reported that he had no symptoms while using the device and had not used it since the prior day at the time of his heart attack.
Patient Sequence No: 1, Text Type: D, B5
[10639648]
Device received back for evaluation on (b)(4) 2013. Completed evaluation on (b)(4) 2013. Findings: the device was clean with no cosmetic defect or damage. There were no signs of wear or excessive use. Isometric exercise therapy protocol functions according to specifications. Isometric exercise squeeze force is within expected tolerances. Device squeeze force sensor responded in a linear fashion and isometric exercise squeeze force levels were within specifications. The device passed all initial function checks and inspections and calibration performance was as expected. Conclusion: the device was within all specifications and there is no indication of a device design, manufacturing or quality issue associated with the consumer's symptoms. Device labeling warns subjects to consult their doctor prior to beginning the zona plus isometric exercise program, but consumer reported he did not do so. Device is hand-grip therapy device originally submitted in k974416 but ultimately found to be 510(k) exempt.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005404127-2013-00001 |
| MDR Report Key | 3030646 |
| Report Source | 04 |
| Date Received | 2013-03-25 |
| Date of Report | 2013-03-20 |
| Date of Event | 2013-02-25 |
| Date Mfgr Received | 2013-03-04 |
| Device Manufacturer Date | 2012-12-01 |
| Date Added to Maude | 2013-04-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | NATHANIEL LONGSTREET, REP. |
| Manufacturer Street | 12554 W. BRIDGER ST. SUITE 108 |
| Manufacturer City | BOISE ID 83713 |
| Manufacturer Country | US |
| Manufacturer Postal | 83713 |
| Manufacturer Phone | 2083229399 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZONA PLUS |
| Generic Name | PROD CODE BXB: HANDGRIP EXERCISE DEVICE |
| Product Code | BXB |
| Date Received | 2013-03-25 |
| Returned To Mfg | 2013-03-18 |
| Model Number | ZONA PLUS V2 |
| Catalog Number | NA |
| Lot Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZONA HEALTH |
| Manufacturer Address | BOISE ID US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2013-03-25 |