MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-20 for ARGON ARTERIAL NEEDLE 195318 manufactured by Argon Medical Devices Inc..
| Report Number | 8716075 |
| MDR Report Key | 8716075 |
| Date Received | 2019-06-20 |
| Date of Report | 2019-04-23 |
| Date of Event | 2019-04-09 |
| Report Date | 2019-04-23 |
| Date Reported to FDA | 2019-04-23 |
| Date Reported to Mfgr | 2019-06-20 |
| Date Added to Maude | 2019-06-20 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | ARGON ARTERIAL NEEDLE |
| Generic Name | GUIDE, NEEDLE, SURGICAL |
| Product Code | GDF |
| Date Received | 2019-06-20 |
| Catalog Number | 195318 |
| Lot Number | 11243540 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 0 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARGON MEDICAL DEVICES INC. |
| Manufacturer Address | 1445 FLAT CREEK RD ATHENS TX 75751 US 75751 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-06-20 |