Brand Name | SPRING ARM |
Type of Device | SPRING ARM |
Manufacturer (Section D) |
OASYS HEALTHCARE |
191 main st n |
uxbridge, on L9P 1 C3 |
|
Manufacturer Contact |
agustin
de paredes
|
55 east wilmot street |
richmond hill, on L4B 1-A3
|
7640800
|
|
MDR Report Key | 5200343 |
MDR Text Key | 30496945 |
Report Number | 3007682310-2015-00001 |
Device Sequence Number | 1 |
Product Code |
KQM
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
user facility |
Reporter Occupation |
Other
|
Remedial Action |
Repair |
Type of Report
| Initial |
Report Date |
10/09/2015 |
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 Model Number | SM-OA91-3AS-A |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
08/04/2015 |
Initial Date FDA Received | 10/20/2015 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 12/01/2013 |
Is the Device Single Use? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
|
|