MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-20 for GENERAL ELECTRIC SIGNAHD28 manufactured by Ge Medical Systems, Llc.
[184816007]
During a routine mri exam of the rectum, the pt acquired a small "kissing burn" just between the thighs. The technologist was made aware after the scan from the pt and was assessed by the radiologist. The radiologist told the pt to get ointment if needed. The pt will then be followed up with each day for 3 days after the initial incident. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093885 |
| MDR Report Key | 9865391 |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-19 |
| Date of Event | 2020-03-18 |
| Date Added to Maude | 2020-03-23 |
| 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 | 3 |
| Brand Name | GENERAL ELECTRIC |
| Generic Name | SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING |
| Product Code | LNH |
| Date Received | 2020-03-20 |
| Model Number | SIGNAHD28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE MEDICAL SYSTEMS, LLC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-20 |