MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-07-11 for HSCA, END USER ACCURATE DIAGNOSTICS manufactured by Brea Discrete Mfg Io.
| Report Number | 2050012-2019-01086 |
| MDR Report Key | 8781424 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-07-11 |
| Date of Report | 2019-07-11 |
| Date of Event | 2019-06-13 |
| Date Facility Aware | 2019-06-13 |
| Date Mfgr Received | 2019-06-13 |
| Device Manufacturer Date | 2013-07-01 |
| Date Added to Maude | 2019-07-11 |
| 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 | MR DAVID DAVIS |
| Manufacturer Street | 250 S. KRAEMER BLVD |
| Manufacturer City | BREA CA 928218000 |
| Manufacturer Country | US |
| Manufacturer Postal | 928218000 |
| Manufacturer G1 | BREA DISCRETE MFG IO |
| Manufacturer Street | 250 S. KRAEMER BLVD |
| Manufacturer City | BREA CA 928218000 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 928218000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HSCA, END USER ACCURATE DIAGNOSTICS |
| Generic Name | RADIOASSAY, VITAMIN B12 |
| Product Code | CDD |
| Date Received | 2019-07-11 |
| Model Number | HSCA, END USER ACCURATE DIAGNOSTICS |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BREA DISCRETE MFG IO |
| Manufacturer Address | 250 S KRAEMER BLVD BREA CA 928218000 US 928218000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-07-11 |