| Brand Name | PROVU UNIVERSAL REUSABLE 8" DISPLAY, CHARGING CABLE AND 2 M AMPLIFIER EXTENSION |
|---|
| Type of Device | VIDEO LARYNGOSCOPE |
|---|
| 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 | 18203944 |
|---|
| MDR Text Key | 328889975 |
|---|
| Report Number | 3006061749-2023-00019 |
|---|
| 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,User Facility,Company Representative |
|---|
| Reporter Occupation |
Other Health Care Professional
|
|---|
| Type of Report
| Initial |
|---|
| Report Date |
11/24/2023 |
|---|
| 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 Catalogue Number | 040-07-0080U |
|---|
| Is the Reporter a Health Professional? |
Yes
|
|---|
| Initial Date Manufacturer Received |
10/26/2023
|
|---|
| Initial Date FDA Received | 11/24/2023 |
|---|
| Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
|---|
| Date Device Manufactured | 02/01/2023 |
|---|
| Is the Device Single Use? |
No
|
|---|
| Is This a Reprocessed and Reused Single-Use Device? |
No
|
|---|
| Type of Device Usage |
Unknown
|
|---|
| Patient Sequence Number | 1 |
|---|
