MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-11-01 for AMERICAN BACK SOLUTIONS, INC. ABS * manufactured by North American Medical.
[20349668]
Table was adverised to reporter as axial spinal decompression, not traction and was advertised as fda approved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1037057 |
| MDR Report Key | 746889 |
| Date Received | 2005-11-01 |
| Date Added to Maude | 2006-08-15 |
| 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 | AMERICAN BACK SOLUTIONS, INC. |
| Generic Name | SPINAL DECOMPRESSION |
| Product Code | JFB |
| Date Received | 2005-11-01 |
| Model Number | ABS |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 734679 |
| Manufacturer | NORTH AMERICAN MEDICAL |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-11-01 |