MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-15 for ARTHROSTIM manufactured by Unk.
[47827219]
The product is called an arthrostim instrument and it is injuring people. It is being sold to chiropractors. It is a mechanized metal instrument with attachments that strike very hard and fast while the finger is holding the trigger. The attachments are made of hard plastic. It is being advertised to use on the cervical vertebrae, particularly the atlas and axis. I only know of medical doctors to use mechanized equipment to treat the cervical vertebrae (equipment which has gone through thorough medical trials) not chiropractors, and i feel this device is illegal. I believe a chiropractor intentionally injured me by using this device which is why i reported the incident to my local police department. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5062922 |
| MDR Report Key | 5735905 |
| Date Received | 2016-06-15 |
| Date of Report | 2016-06-15 |
| Date of Event | 2016-06-02 |
| Date Added to Maude | 2016-06-20 |
| 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 | ARTHROSTIM |
| Generic Name | ARTHROSTIM |
| Product Code | LXM |
| Date Received | 2016-06-15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention; 2. Deathisabilit | 2016-06-15 |