MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-04-14 for INVIVO SENSE XL TORSO MRI COIL manufactured by Invivo.
[18368714]
Philips mri 1. 5t achieva scanner was utilized on pt for scan of lower extremities. During the scan the pt expressed feeling heat or burning feeling of his left upper medial thigh. Upon technician assessment no burn was assessed. After completion of the scan, the pt indicated to the technician, the pt now had 2 burns. The technician reassessed the pt and confirmed the presence of the 2 quarter sized burns. The pt was treated for second degree burns in the ed of our facility. The mri coil was taken out of service and our biomed staff notified philips. The coil is an invivo sense xl torso coil. Our risk management took pictures of the coil and we plan to provide the coil back to philips for failure mode testing. Diagnosis or reason for use: appliance is necessary to create image on mri scan. Event abated after use stopped or dose reduced: yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5035662 |
| MDR Report Key | 3757108 |
| Date Received | 2014-04-14 |
| Date of Report | 2014-04-11 |
| Date of Event | 2014-04-07 |
| Date Added to Maude | 2014-04-18 |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INVIVO SENSE XL TORSO MRI COIL |
| Generic Name | INVIVO SENSE XL TORSO MRI COIL |
| Product Code | MOS |
| Date Received | 2014-04-14 |
| ID Number | 453567502284 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INVIVO |
| Manufacturer Address | NL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-04-14 |