MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2012-02-20 for ZONA PLUS ZONA PLUS V2 manufactured by Zona Health.
[2521941]
A consumer initially contacted the company on (b)(6) 2012 requesting a refund for her zona plus device. By follow-up email on 2/1/2012, the consumer reported that she purchased the device on (b)(6) 2011 and used the device on (b)(6) 2011. She reported that on (b)(6) 2011, her right arm and hand felt numb while sitting but after a while the feeling came back. She reported that sometime between (b)(6), she used the device immediately prior to bedtime. She reported that when she awoke the next morning, her hand was numb and has remained so since that time. She reported that her hand is weak and that she has numbness on the outside of her right hand in the last 2 fingers of her right hand. She also reported feelings of tingling, discomfort, and tightness and that she is unable to straighten her little finger and unable to spread all of the fingers completely apart. The consumer reported that these symptoms did not exist prior to using the device, and that the symptoms are continuing. The consumer believes the symptoms were caused by repetitive use of the device and that this is because she used the zona plus right before bedtime and awoke with the symptoms the next day.
Patient Sequence No: 1, Text Type: D, B5
[9652056]
Device received back for evaluation on 2/14/2012. Completed evaluation on 2/15/2012. 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 she did not do so. Device is a handgrip therapy device originally submitted in k974416 but ultimately found to be 510 (k) exempt.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005404127-2012-00001 |
| MDR Report Key | 2465271 |
| Report Source | 04 |
| Date Received | 2012-02-20 |
| Date of Report | 2012-01-23 |
| Date of Event | 2012-09-03 |
| Date Mfgr Received | 2012-01-23 |
| Device Manufacturer Date | 2010-11-22 |
| Date Added to Maude | 2012-02-24 |
| 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, QUALITY 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 | BXB: HANDGRIP EXERCISE DEVICE |
| Product Code | BXB |
| Date Received | 2012-02-20 |
| Returned To Mfg | 2012-02-14 |
| Model Number | ZONA PLUS V2 |
| Catalog Number | NA |
| Lot Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| 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. Deathisabilit | 2012-02-20 |