MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-11-30 for * UNK manufactured by Unk.
[15687890]
Pt had a disc that bulged to the right side. Pt visited a chiropractor who treated her. The first 8 months was good. Subsequently pt was trapped with the device and the back hurt very badly when she went for the therapy. Visited the chiropractor who informed pt that the machine was made for taller people after nine visits of therapy. Pt finds it difficult to walk with herniated disc on left side and numbness too.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1037207 |
| MDR Report Key | 654092 |
| Date Received | 2005-11-30 |
| Date of Report | 2005-11-30 |
| Date of Event | 2005-09-01 |
| Date Added to Maude | 2005-12-21 |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | D-R X9000 |
| Product Code | ITH |
| Date Received | 2005-11-30 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 643560 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-11-30 |