Brand Name | PROVU UNIVERSAL 8" DISPLAY, CHARGING CABLE AND 2M AMPLIFING EXTENSION CABLE |
Type of Device | LARYNGOSCOPE |
Manufacturer (Section D) |
FLEXICARE MEDICAL LTD |
cynon valley business park |
mountain ash, CF45 4ER |
UK CF45 4ER |
|
Manufacturer (Section G) |
FLEXICARE MEDICAL DONGGUAN |
no. b-15 xicheng ind zone 1 |
hengli town |
dongguan city, guangdong 52346 0 |
CH
523460
|
|
Manufacturer Contact |
julie
davies
|
cynon valley business park |
mountain ash, rct CF45 -4ER
|
UK
CF45 4ER
|
|
MDR Report Key | 16252258 |
MDR Text Key | 309016349 |
Report Number | 3006061749-2023-00001 |
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 |
Health Professional,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
01/27/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | 040-07-0080U |
Device Lot Number | NOT GIVEN |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
12/30/2022 |
Initial Date FDA Received | 01/27/2023 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |