MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-11-06 for MICK RADIO-NUCLEAR MOLENSTRAAT 15 17 GUAGE X 25CM manufactured by Mrni.
[4993270]
Vaginal flaxiguide needles were planned under ultrasound and template guidance and the patient had a mri and ct for treatment planning. When the patient returned to the radiation oncology area, it was noticed that one needle was shorter and it was removed. On inspection, 3mm of the tip was noted to be missing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5039058 |
| MDR Report Key | 4253546 |
| Date Received | 2014-11-06 |
| Date of Report | 2014-11-06 |
| Date of Event | 2014-10-27 |
| Date Added to Maude | 2014-11-18 |
| 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 | MICK RADIO-NUCLEAR |
| Generic Name | FLEXI-GUIDE MICK |
| Product Code | JAQ |
| Date Received | 2014-11-06 |
| Model Number | MOLENSTRAAT 15 |
| Catalog Number | 17 GUAGE X 25CM |
| Lot Number | 110216-02 |
| Device Expiration Date | 2015-01-31 |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MRNI |
| Manufacturer Address | MOUNT VERNON NY 10550 US 10550 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-11-06 |