Brand Name | SAVARIA |
Type of Device | SL 1000 |
Manufacturer (Section D) |
SAVARIA CONCORD LIFTS INC |
2 walker drive |
brampton, ontario L6T5E 1 |
CA L6T5E1 |
|
Manufacturer (Section G) |
SAVARIA CONCORD LIFTS INC |
2 walker drive |
|
brampton, ontario L6T5E 1 |
CA
L6T5E1
|
|
Manufacturer Contact |
william
richardson
|
2 walker drive |
brampton, ontario L6T5E-1
|
CA
L6T5E1
|
7995555
|
|
MDR Report Key | 6554074 |
MDR Text Key | 74905956 |
Report Number | 3005753836-2016-00004 |
Device Sequence Number | 1 |
Product Code |
PCD
|
Combination Product (y/n) | N |
Reporter Country Code | CA |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative |
Reporter Occupation |
Medical Equipment Company Technician/Representative
|
Remedial Action |
Repair |
Type of Report
| Initial |
Report Date |
07/11/2016 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 05/09/2017 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Patient Family Member or Friend
|
Device Model Number | SL 1000 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 01/12/2015 |
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Event Location |
Home
|
Was Device Evaluated by Manufacturer? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |