MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-03 for GE SIGNA HD XT 2225252-7 manufactured by Ge Healthcare.
[82037057]
Mri of the right shoulder. Patient returned to the facility the following day with second degree burns to the anterior and posterior aspect of the right shoulder. The patient was imaged with a patient gown and no direct contact with the shoulder coil occurred. Patient was seen in the er and released with no further issues.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5071394 |
| MDR Report Key | 6771076 |
| Date Received | 2017-08-03 |
| Date of Report | 2017-07-19 |
| Date of Event | 2017-07-07 |
| Date Added to Maude | 2017-08-07 |
| 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 | RADIOLOGIC TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | GE SIGNA HD XT |
| Generic Name | SMALL SHOULDER ARRAY COIL (REC) |
| Product Code | MOS |
| Date Received | 2017-08-03 |
| Returned To Mfg | 2017-07-09 |
| Catalog Number | 2225252-7 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE HEALTHCARE |
| Manufacturer Address | WAUKESHA WI US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-08-03 |