Brand Name | BRITEPRO SOLO |
Type of Device | LAYRYNOSCOPE |
Manufacturer (Section D) |
FLEXICARE MEDICAL LTD |
cwm cynon business park |
mountain ash, rct CF45 4ER |
UK CF45 4ER |
|
Manufacturer (Section G) |
FLEXICARE MEDICAL LTD (CHINA) |
no.b-15 |
xicheng industrial zone |
dongguan, guangdong 52346 5 |
CH
523465
|
|
Manufacturer Contact |
julie
davies
|
cwm cynon business park |
mountain ash, rct CF45 -4ER
|
UK
CF45 4ER
|
|
MDR Report Key | 18865217 |
MDR Text Key | 337346989 |
Report Number | 3006061749-2024-00006 |
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 |
Manufacturer
|
Source Type |
User Facility,Company Representative |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
03/08/2024 |
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 Catalogue Number | 040-343U |
Device Lot Number | 201202371 & 201101150 |
Initial Date Manufacturer Received |
02/06/2024
|
Initial Date FDA Received | 03/08/2024 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 11/01/2020 |
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 |
|
|