MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-10-03 for LEADCARE II BLOOD LEAD TEST SYSTEM 70-6529-P manufactured by Magellan Diagnostics, Inc..
| Report Number | 1218996-2019-00019 |
| MDR Report Key | 9150897 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-10-03 |
| Date of Report | 2019-10-03 |
| Date of Event | 2018-11-17 |
| Date Mfgr Received | 2018-11-17 |
| Device Manufacturer Date | 2016-03-01 |
| Date Added to Maude | 2019-10-03 |
| 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. IVY MARGARET THIONG'O |
| Manufacturer Street | 101 BILLERICA AVE. BUILDING 4 |
| Manufacturer City | N. BILLERICA MA 01862 |
| Manufacturer Country | US |
| Manufacturer Postal | 01862 |
| Manufacturer Phone | 9783135480 |
| Manufacturer G1 | MAGELLAN DIAGNOSTICS, INC. |
| Manufacturer Street | 101 BILLERICA AVE. BUILDING 4 |
| Manufacturer City | N. BILLERICA MA 01862 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01862 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEADCARE II BLOOD LEAD TEST SYSTEM |
| Generic Name | LEADCARE II ANALYZER |
| Product Code | DOF |
| Date Received | 2019-10-03 |
| Returned To Mfg | 2018-11-29 |
| Model Number | 70-6529-P |
| Catalog Number | 70-6529-P |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAGELLAN DIAGNOSTICS, INC. |
| Manufacturer Address | 101 BILLERICA AVE BUILDING 4 N. BILLERICA MA 01862 US 01862 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-10-03 |