MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-17 for EMG manufactured by Unk.
[131002538]
I was tested by an emg device at maximum setting which put me into electro convulsions which eventually tore my bicep muscle nerves tendons at the site where my phone had broken 34 years previously which put me into so much pain. I almost passed out. I have not felt this pain so intense in 34 years. They should have a governor on these emg machines so people cannot abuse them, and there should be warning labels on the machine and in the booklets an instruction manual so that the dr is reminded as well as i will be notified there is possible danger involved. This experience was horrendous and i consider it torture.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5082256 |
| MDR Report Key | 8176327 |
| Date Received | 2018-12-17 |
| Date of Report | 2018-12-14 |
| Date of Event | 2018-08-28 |
| Date Added to Maude | 2018-12-18 |
| 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 | EMG |
| Generic Name | ELECTROMYOGRAPH, DIAGNOSTIC |
| Product Code | IKN |
| Date Received | 2018-12-17 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Deathisabilit | 2018-12-17 |