Brand Name | MCGRATH |
Type of Device | LARYNGOSCOPE, RIGID |
Manufacturer (Section D) |
AIRCRAFT MEDICAL LIMITED |
7 cross way |
dalgety bay,fi KY11 9JE |
GB KY11 9JE |
|
Manufacturer (Section G) |
AIRCRAFT MEDICAL LIMITED |
7 cross way |
|
dalgety bay,fi KY11 9JE |
GB
KY11 9JE
|
|
Manufacturer Contact |
avi
kluger
|
5920 longbow drive |
boulder, CO 80301
|
3035306582
|
|
MDR Report Key | 8641078 |
MDR Text Key | 146100492 |
Report Number | 3010244187-2019-00005 |
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 |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
05/24/2019 |
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 Expiration Date | 10/19/2021 |
Device Model Number | 300-000-000 |
Device Catalogue Number | 300-000-000 |
Device Lot Number | P18101901 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
05/01/2019
|
Initial Date FDA Received | 05/24/2019 |
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 |
|
|