MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-06-29 for UNK manufactured by Unk.
[506117]
Following a vehicular assault in 10/2000; sought treatment for neck and upper back pain. Referred to a chiropractor who utilized a device known as an activator adjusting instrument. The following injuries resulted. Tinnitus, tbi, fibromyalgia and damage to parasympathetic nerves. Damage to base of skull reveals c5, c6, c4-c5 mild disc osteophyte complex causing mild effacement of the ventral thecal sac and relative mild central canal narrowing. C5-c6 disc osteophyte complex greatest in the right paracentral region causing relative central canal narrowing and mild mass effect on the ventral cords. Mild disc bulge at t2-t3.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1035897 |
| MDR Report Key | 754882 |
| Date Received | 2005-06-29 |
| Date Added to Maude | 2006-08-29 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNK |
| Generic Name | ACTIVATOR ADJUSTING INSTRUMENT |
| Product Code | JFB |
| Date Received | 2005-06-29 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 742693 |
| Manufacturer | UNK |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention; 4. Deathisabilit | 2005-06-29 |