Brand Name | HUDSON MASK,NON-REBREATH W/O SAFETY VENT,ELONG |
Type of Device | MASK, OXYGEN, NON-REBREATHING |
Manufacturer (Section D) |
TELEFLEX MEDICAL |
morrisville NC |
|
MDR Report Key | 11058417 |
MDR Text Key | 223753446 |
Report Number | 3004365956-2020-00272 |
Device Sequence Number | 1 |
Product Code |
KGB
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,distri |
Type of Report
| Initial |
Report Date |
12/08/2020 |
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 |
No Information
|
Device Catalogue Number | 1060 |
Device Lot Number | 74F1900297 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
12/08/2020
|
Initial Date FDA Received | 12/22/2020 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 06/05/2019 |
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 |
|
|