MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-11 for GE manufactured by Ge.
[65026638]
Pt presented with bilateral blister on inner thigh post mri of lower extremity. Per pt's physician the blisters were small and did not require treatment, no burn cream was administered. Mri safety officer/ physicist (b)(6) came out as did ge field service engineer to investigate on 01/04/2017. The coil was taken out of use on (b)(6) 2017 when the pt's physician alerted mr of the incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5067195 |
| MDR Report Key | 6249083 |
| Date Received | 2017-01-11 |
| Date of Report | 2017-01-09 |
| Date of Event | 2016-12-31 |
| Date Added to Maude | 2017-01-13 |
| 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 |
| Generic Name | ANTERIOR ARRAY COIL |
| Product Code | MOS |
| Date Received | 2017-01-11 |
| Returned To Mfg | 2017-01-04 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-11 |