MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-24 for ULTRA-TACHYON MICRODISK manufactured by Advanced Tachyon Technologies.
[50388344]
Caller stated he suffered from advanced arthritis in his knees and was encouraged by a friend on utilize an ultra-tachyon disk. The caller's friend bought it for her mother and it relieved her pain. The caller reported after 1 day, he discontinued use due to the disk causing him excruciating pain and sleep disturbances. Caller went to a masseuse to help relieve his inflamed knee and lower thigh. Caller stated he felt the device moving and was concerned that this device could have more unk negative effects. Caller added, the company's website (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5063573 |
| MDR Report Key | 5815024 |
| Date Received | 2016-05-24 |
| Date of Report | 2016-05-24 |
| Date of Event | 2016-05-20 |
| Date Added to Maude | 2016-07-22 |
| 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 | 3 |
| Brand Name | ULTRA-TACHYON MICRODISK |
| Generic Name | ULTRA-TACHYON MICRODISK |
| Product Code | OMW |
| Date Received | 2016-05-24 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ADVANCED TACHYON TECHNOLOGIES |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-05-24 |