Brand Name | RUSCH GREENLITE DISP MTL MAC 4 |
Type of Device | LARYNGOSCOPE, RIGID |
Manufacturer (Section D) |
|
Manufacturer (Section G) |
TRUPHATEK INTERNATIONAL LTD. |
14 benny gaon street |
p.o. 8051 |
netanya 42504 43 |
IS
4250443
|
|
Manufacturer Contact |
katharine
tarpley
|
3015 carrington mill blvd |
morrisville, NC 27560
|
|
MDR Report Key | 18745993 |
MDR Text Key | 335810379 |
Report Number | 8030121-2024-00006 |
Device Sequence Number | 1 |
Product Code |
CCW
|
Combination Product (y/n) | N |
Reporter Country Code | FR |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,User Facility,Company Representative |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
01/29/2024 |
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 Model Number | IPN923885 |
Device Catalogue Number | 004551004 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
01/29/2024
|
Initial Date FDA Received | 02/21/2024 |
Supplement Dates Manufacturer Received | 01/29/2024
|
Supplement Dates FDA Received | 03/05/2024
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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 |
Treatment | NOT REPORTED; NOT REPORTED |
|
|