MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-03-31 for QUALITY ELECTRODYNAMICS Q7000074 QED000074 manufactured by Quality Electrodynamics, Llc.
| Report Number | 3007350713-2020-03311 |
| MDR Report Key | 9903853 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-01-30 |
| Date Mfgr Received | 2020-03-05 |
| Device Manufacturer Date | 2018-03-29 |
| Date Added to Maude | 2020-03-31 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | MS KATHLEEN ARAS |
| Manufacturer Street | 6655 BETA DRIVE SUITE 100 |
| Manufacturer City | MAYFIELD VILLAGE, OH |
| Manufacturer Country | US |
| Manufacturer Phone | 8326481 |
| Manufacturer G1 | QUALITY ELECTRODYNAMICS, LLC |
| Manufacturer Street | 6655 BETA DRIVE SUITE 100 |
| Manufacturer City | MAYFIELD VILLAGE, OH |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | QUALITY ELECTRODYNAMICS |
| Generic Name | 3T 18CH KNEE COIL |
| Product Code | MOS |
| Date Received | 2020-03-31 |
| Model Number | Q7000074 |
| Catalog Number | QED000074 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | QUALITY ELECTRODYNAMICS, LLC |
| Manufacturer Address | 6655 BETA DRIVE SUITE 100 MAYFIELD VILLAGE, OH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-31 |