MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-01-11 for TOFTNESS DEVICE 524 NA manufactured by Toftness Post-graduate School Of Chiropractic, Inc..
[20991800]
Toftness device in use by a chiropractor for adjusting the spine. Distribution/use of unapproved medical device. No injury resulted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4002673 |
| MDR Report Key | 259801 |
| Date Received | 2000-01-11 |
| Date of Report | 1999-12-22 |
| Date Added to Maude | 2000-01-28 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TOFTNESS DEVICE |
| Generic Name | SPINE ADJUSTING DEVICE |
| Product Code | JFB |
| Date Received | 2000-01-11 |
| Model Number | 524 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 251605 |
| Manufacturer | TOFTNESS POST-GRADUATE SCHOOL OF CHIROPRACTIC, INC. |
| Manufacturer Address | 1310 GROVE ST. CUMBERLAND WI 54829 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-01-11 |