MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-07-30 for SPINAL DECOMPRESSION DEVICE DRX 9000 manufactured by .
[20223163]
Operator reports that the device is being misassembled by global decompression company. She was repairing the device when she realized this error. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5026320 |
| MDR Report Key | 2677531 |
| Date Received | 2012-07-30 |
| Date of Report | 2012-07-30 |
| Date Added to Maude | 2012-08-02 |
| 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 | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPINAL DECOMPRESSION DEVICE |
| Generic Name | DRX 9000 SPINAL DECOMPRESSION |
| Product Code | ITH |
| Date Received | 2012-07-30 |
| Model Number | DRX 9000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-07-30 |