Brand Name | OXYMASK ADULT ETCO2 |
Type of Device | OXYMASK |
Manufacturer (Section D) |
SOUTHMEDIC, INC. |
50 alliance blvd. |
barrie, ontario L4M 5 K3 |
CA L4M 5K3 |
|
Manufacturer (Section G) |
SOUTHMEDIC, INC. |
50 alliance blvd. |
|
barrie, ontario L4M 5 K3 |
CA
L4M 5K3
|
|
Manufacturer Contact |
tish
whitehead
|
50 alliance blvd. |
barrie, ontario L4M 5-K3
|
CA
L4M 5K3
|
|
MDR Report Key | 7663815 |
MDR Text Key | 113417362 |
Report Number | 8022032-2018-00001 |
Device Sequence Number | 1 |
Product Code |
CCK
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K014211 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional |
Reporter Occupation |
Nurse
|
Remedial Action |
Recall |
Type of Report
| Initial |
Report Date |
02/13/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 07/05/2018 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
No Information
|
Device Model Number | OM-2125-8 |
Device Catalogue Number | OM-2125-8 |
Device Lot Number | W37743 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 02/01/2018 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 04/04/2017 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
|
|