Brand Name | RUSCH POLARIS FO BLADE MAC 4 |
Type of Device | LARYNGOSCOPE, RIGID |
Manufacturer (Section D) |
|
Manufacturer (Section G) |
TELEFLEX MEDICAL |
3015 carrington mill blvd |
|
morrisville NC 27560 |
|
Manufacturer Contact |
katharine
tarpley
|
3015 carrington mill blvd |
morrisville, NC 27560
|
9193614124
|
|
MDR Report Key | 15146224 |
MDR Text Key | 301569936 |
Report Number | 3011137372-2022-00164 |
Device Sequence Number | 1 |
Product Code |
CCW
|
UDI-Device Identifier | 14026704711830 |
UDI-Public | 14026704711830 |
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,Distributor |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
07/05/2022 |
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 Model Number | IPN915503 |
Device Catalogue Number | 4150140 |
Device Lot Number | AB2111006 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
07/05/2022
|
Initial Date FDA Received | 08/02/2022 |
Supplement Dates Manufacturer Received | 08/22/2022
|
Supplement Dates FDA Received | 08/22/2022
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 08/08/2021 |
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 |
|
|