MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-09-21 for COMMANDER XG RMT-RTC2K UNK manufactured by Reasonance Technolgies, Inc..
[19892410]
Pt undergoing mri lumbar spine exam on ge 1. 5t excite while wearing resonance technologies cinema goggles complained after exam of heating to the face at point of contact with goggles. On follow up the next day, pt stated tiny blisters had formed on forehead.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1036662 |
| MDR Report Key | 735529 |
| Date Received | 2005-09-21 |
| Date of Report | 2005-09-20 |
| Date of Event | 2005-08-25 |
| Date Added to Maude | 2006-07-19 |
| 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 | COMMANDER XG |
| Generic Name | CINEMA VISION |
| Product Code | HOY |
| Date Received | 2005-09-21 |
| Model Number | RMT-RTC2K |
| Catalog Number | UNK |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 723419 |
| Manufacturer | REASONANCE TECHNOLGIES, INC. |
| Manufacturer Address | * NORTHRIDGE CA * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-09-21 |