Brand Name | OSOM HCG COMBO TEST |
Type of Device | VISUAL, PREGNANCY HCG, PRESCRIPTION USE |
Manufacturer (Section D) |
SEKISUI DIAGNOSTICS, LLC |
6740 cobra way |
san diego CA 92121 |
|
MDR Report Key | 16214011 |
MDR Text Key | 307780247 |
Report Number | 16214011 |
Device Sequence Number | 1 |
Product Code |
JHI
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Reporter Occupation |
Risk Manager
|
Type of Report
| Initial |
Report Date |
12/29/2022,12/28/2022 |
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 Lot Number | 221418 |
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 12/29/2022 |
Event Location |
Ambulatory Surgical Facility
|
Date Report to Manufacturer | 01/20/2023 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 01/20/2023 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
|
|