Brand Name | LEADCARE II TEST KIT |
Type of Device | LEAD, ATOMIC ABSORPTION |
Manufacturer (Section D) |
MAGELLAN DIAGNOSTICS, INC. |
n. billeria MA 01862 |
|
MDR Report Key | 12933939 |
MDR Text Key | 281906105 |
Report Number | MW5105796 |
Device Sequence Number | 1 |
Product Code |
DOF
|
UDI-Device Identifier | 00850355006000 |
UDI-Public | 0100850355006000 |
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Voluntary
|
Reporter Occupation |
Administrator/Supervisor
|
Type of Report
| Initial |
Report Date |
12/01/2021 |
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 Expiration Date | 06/16/2022 |
Device Lot Number | 2018M |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 12/03/2021 |
Patient Sequence Number | 1 |
Patient Age | 2 YR |
Patient Sex | Male |
Patient Weight | 14 KG |
|
|