MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-03 for ELECTRONIC PULSE MASSAGER YK15AB manufactured by Healthmate Forever Llc.
[42267450]
I have received shock therapy at a health clinic for cubital tunnel syndrome. They suggested i get a device with the same shock therapy concept. I got this because it was supposedly fda approved. The first and lowest setting was already stronger and painful to use. I gave it the benefit of the doubt and tried it on my thigh and still the lowest setting was too much. My wife tried this, (b)(6), and she cried the moment it was turned on. This product is dangerous and i have no idea how it has fda approval or this many sales without being shutdown. I have had nerve pains that have been lingering for 2 days after using that product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5061504 |
| MDR Report Key | 5553729 |
| Date Received | 2016-04-03 |
| Date of Report | 2016-04-03 |
| Date of Event | 2016-03-26 |
| Date Added to Maude | 2016-04-07 |
| 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 | ELECTRONIC PULSE MASSAGER |
| Generic Name | TENS UNIT |
| Product Code | NGX |
| Date Received | 2016-04-03 |
| Model Number | YK15AB |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HEALTHMATE FOREVER LLC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-04-03 |