MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-25 for LEADCARE II BLOOD LEAD TEST SYSTEM 70-6529 70-6760 manufactured by Magellan Diagnostic, Inc.
Report Number | 1218996-2020-00001 |
MDR Report Key | 9880025 |
Date Received | 2020-03-25 |
Date of Report | 2020-03-26 |
Date of Event | 2020-02-26 |
Date Mfgr Received | 2020-02-26 |
Device Manufacturer Date | 2011-04-14 |
Date Added to Maude | 2020-03-25 |
Event Key | 0 |
Report Source Code | Manufacturer report |
Manufacturer Link | Y |
Number of Patients in Event | 0 |
Adverse Event Flag | 0 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 3 |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Contact | MS. NICOLE INESON |
Manufacturer Street | 101 BILLERICA AVE BUILDING 4 |
Manufacturer City | NORTH BILLERICA, MA |
Manufacturer Country | US |
Manufacturer Phone | 3135478 |
Manufacturer G1 | MAGELLAN DIAGNOSTIC, INC. |
Manufacturer Street | 101 BILLERICA AVE BUILDING 4 |
Manufacturer City | NORTH BILLERICA, MA |
Manufacturer Country | US |
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 | 2020-03-25 |
Returned To Mfg | 2020-03-06 |
Model Number | 70-6529 |
Catalog Number | 70-6760 |
Operator | HEALTH PROFESSIONAL |
Device Availability | R |
Device Eval'ed by Mfgr | Y |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | MAGELLAN DIAGNOSTIC, INC |
Manufacturer Address | 101 BILLERICA AVE BUILDING 4 NORTH BILLERICA, MA US |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2020-03-25 |