MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-25 for LARGE FLEX COIL 2273180-3 NA manufactured by Ge Healthcare Japan Corporation.
[66078325]
Patient completed lumbar spine mri no contrast exam. Technologist noticed skin rash, burn and pink.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5067508 |
| MDR Report Key | 6282840 |
| Date Received | 2017-01-25 |
| Date of Report | 2017-01-03 |
| Date of Event | 2016-12-21 |
| Date Added to Maude | 2017-01-27 |
| 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 | RISK MANAGER |
| 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 | LARGE FLEX COIL |
| Generic Name | LARGE FLEX COIL |
| Product Code | MOS |
| Date Received | 2017-01-25 |
| Model Number | 2273180-3 |
| Catalog Number | NA |
| Lot Number | NA |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE HEALTHCARE JAPAN CORPORATION |
| Manufacturer Address | JA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-01-25 |