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 |