MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-10-22 for VAX D * manufactured by Unk.
[17021461]
Pt recently had a vax d treatment. Pt was strapped into safety belt and a shoulder collar and laid on machine the machine turned on. Pt suffered a severe shooting pain and had no way to shut down the machine and the dr had left the room. Pt was in pain for another 5-10 mins till he returned. Pt suffered severe pain on way home and still feels the pain but it has lessened some. Point is there should be a emergency stop within the reach of the pt should any emergency arise, shouting pain or even a cardiac emergency could happen. How hard would it be to have a panic stop next to pt's hand. Pt feels this modification should be done right away. There is up to 80 lbs of pressure on a pt when something bad could happen. Drs are distracted by phone calls, other pts or even a bathroom break and pt is strapped to a machine in possible harmful pain.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4003835 |
| MDR Report Key | 563576 |
| Date Received | 2004-10-22 |
| Date Added to Maude | 2005-01-07 |
| 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 | VAX D |
| Generic Name | * |
| Product Code | ITH |
| Date Received | 2004-10-22 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 553305 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-10-22 |