Brand Name | LEADCARE II BLOOD LEAD TEST SYSTEM |
Type of Device | LEADCARE II ANALYZER |
Manufacturer (Section D) |
MAGELLAN DIAGNOSTICS, INC |
101 billerica ave |
building 4 |
north billerica, ma |
|
Manufacturer (Section G) |
MAGELLAN DIAGNOSTICS, INC |
101 billerica ave |
building 4 |
north billerica, ma |
|
Manufacturer Contact |
nicole
ineson
|
101 billerica ave |
building 4 |
north billerica, ma
|
3135478
|
|
MDR Report Key | 9891539 |
MDR Text Key | 195153881 |
Report Number | 1218996-2020-00002 |
Device Sequence Number | 1 |
Product Code |
DOF
|
UDI-Device Identifier | 00850355006017 |
UDI-Public | 00850355006017 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K052549 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional |
Reporter Occupation |
Nurse
|
Type of Report
| Initial |
Report Date |
03/27/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 70-6529 |
Device Catalogue Number | 70-6760 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
03/23/2020 |
Initial Date FDA Received | 03/27/2020 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
|
|