MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-08-08 for SENSE XL TORSO COIL 453567502284 manufactured by Philips Healthcare.
[4812629]
Patient undergoing mri under anesthesia sustained second degree burns to bilateral thighs and 2 fingertips.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5038004 |
| MDR Report Key | 4055961 |
| Date Received | 2014-08-08 |
| Date of Report | 2014-08-07 |
| Date of Event | 2014-07-31 |
| Date Added to Maude | 2014-09-04 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | SENSE XL TORSO COIL |
| Generic Name | TORSO COIL FOR MRI |
| Product Code | MOT |
| Date Received | 2014-08-08 |
| Model Number | 453567502284 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS HEALTHCARE |
| Manufacturer Address | ANDOVER 01810 01810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-08-08 |