Brand Name | LEAD ANALYZER SYSTEM |
Type of Device | LEAD ANALYZER SYSTEM (PRE-AMENDMENT) |
Manufacturer (Section D) |
MAGELLAN DIAGNOSTICS, INC. |
101 billerica ave |
building 4 |
n. billerica MA 01862 |
|
Manufacturer (Section G) |
MAGELLAN DIAGNOSTICS, INC. |
101 billerica ave |
building 4 |
n. billerica MA 01862 |
|
Manufacturer Contact |
heather
reed
|
101 billerica ave. |
building 4 |
n. billerica, MA 01862
|
9782484811
|
|
MDR Report Key | 8027098 |
MDR Text Key | 127254382 |
Report Number | 1218996-2018-00033 |
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 | PREAMENDMENT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
10/31/2018 |
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 |
Other
|
Device Catalogue Number | 70-1070-3010B |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
08/17/2011 |
Initial Date FDA Received | 10/31/2018 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 09/26/2008 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |