MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-07-19 for SIEMENS 1.5 TESLA ESPREE WITH DEDICATED EXTREMITY COIL manufactured by Siemens Medical Solutions, U.s.a..
[2135671]
Pt underwent mri of the right knee without contrast. Reportedly, during the scan, the pt complained of pain in her calves. Upon completion of the study, the pt complained of a burning feeling. The pt's skin was inspected while she was still in the department and two dime sized superficial circles were identified on the calf. The pt reported hours later that the area had worsened. Dates of use: (b)(6) 2011. Diagnosis or reason for use: mri study.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5021447 |
| MDR Report Key | 2175207 |
| Date Received | 2011-07-19 |
| Date of Report | 2011-07-19 |
| Date of Event | 2011-07-16 |
| Date Added to Maude | 2011-07-29 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| 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 | SIEMENS 1.5 TESLA ESPREE WITH DEDICATED EXTREMITY COIL |
| Product Code | MRI |
| Date Received | 2011-07-19 |
| Model Number | TESLA ESPREE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS MEDICAL SOLUTIONS, U.S.A. |
| Manufacturer Address | 51 VALLEY STREAM PARKWAY MALVERN PA 19355 US 19355 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-07-19 |