MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-10-31 for QED KNEE COIL manufactured by Qed.
[3940885]
Pt having a mri exam of right knee. Almost at end of the exam pt complaint of knee burning. Exam stopped rn and radiologist examined pt. Small are of pinkish / red area on anterior right knee, which appeared to be a (possible) burn from the coil. Pt stated that his symptoms were pretty much gone. Pt advised that if symptoms seem to get worse to contact his physician or to go to the local emergency room.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5032527 |
| MDR Report Key | 3453182 |
| Date Received | 2013-10-31 |
| Date of Report | 2013-10-30 |
| Date of Event | 2013-10-29 |
| Date Added to Maude | 2013-11-07 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | QED KNEE COIL |
| Generic Name | QED KNEE COIL |
| Product Code | MOS |
| Date Received | 2013-10-31 |
| ID Number | 10185464 MATERIAL NUMBER |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | QED |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-10-31 |