MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-16 for GE ANTERIOR ARRAY MRI COIL GE ANTERIOR ARRAY COIL manufactured by Ge Healthcare Co., Ltd..
[133579814]
The pt had 2 small pea size burn marks on upper mid inner thigh after an mri scan of the prostate. Mri system was a ge artist 1. 5 widebore. The coil used was ge anterior array in conjunction with gem hnu posterior coil.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5083198 |
| MDR Report Key | 8257004 |
| Date Received | 2019-01-16 |
| Date of Report | 2019-01-15 |
| Date of Event | 2019-01-14 |
| Date Added to Maude | 2019-01-17 |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | GE ANTERIOR ARRAY MRI COIL |
| Generic Name | COIL MAGNETIC RESONANCE, SPECIALTY |
| Product Code | MOS |
| Date Received | 2019-01-16 |
| Model Number | GE ANTERIOR ARRAY COIL |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE HEALTHCARE CO., LTD. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-01-16 |