Brand Name | BRITEPRO SOLO |
Type of Device | LARYNGOSCOPE, RIGID |
Manufacturer (Section D) |
|
MDR Report Key | 16682452 |
MDR Text Key | 312863155 |
Report Number | MW5116301 |
Device Sequence Number | 1 |
Product Code |
CCW
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Voluntary
|
Reporter Occupation |
Risk Manager
|
Type of Report
| Initial |
Report Date |
04/03/2023 |
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 | 040-309U |
Device Lot Number | 200606055 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 04/04/2023 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Age | 2 MO |
Patient Sex | Male |
Patient Ethnicity | Hispanic |
|
|