Brand Name | AMNISURE ROM TEST |
Type of Device | AMNISURE ROM TEST |
Manufacturer (Section D) |
QIAGEN SCIENCES, LLC |
19300 germantown rd |
germantown, md |
|
Manufacturer (Section G) |
QIAGEN SCIENCES, LLC |
19300 germantown road |
|
germantown, md |
|
Manufacturer Contact |
donna
sowers
|
19300 germantown road |
germantown, md
|
6867876
|
|
MDR Report Key | 9730231 |
MDR Text Key | 188701073 |
Report Number | 1122376-2020-00001 |
Device Sequence Number | 1 |
Product Code |
NQM
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K081767 |
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 |
02/19/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 02/19/2020 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 07/14/2022 |
Device Model Number | FMRT-1 |
Device Catalogue Number | FMRT-1-25-US |
Device Lot Number | 56307021 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 12/02/2019 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 09/09/2019 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
|
|