Brand Name | ROLLATOR 9153651315 |
Type of Device | WALKER, MECHANICAL |
Manufacturer (Section D) |
DOLOMITE AB |
vaxjovagen 303 |
343 75 dio |
SW |
|
Manufacturer (Section G) |
DOLOMITE AB |
vaxjovagen 303 |
|
343 75 dio |
SW
|
|
Manufacturer Contact |
kevin
guyton
|
one invacare way |
elyria, OH 44036
|
8003336900
|
|
MDR Report Key | 4376050 |
MDR Text Key | 5285849 |
Report Number | 9615290-2014-00224 |
Device Sequence Number | 1 |
Product Code |
ITJ
|
Combination Product (y/n) | N |
Reporter Country Code | CA |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Distributor |
Reporter Occupation |
Medical Equipment Company Technician/Representative
|
Type of Report
| Initial |
Report Date |
12/10/2014 |
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 |
Lay User/Patient
|
Device Model Number | JAZZLOW |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
12/10/2014 |
Initial Date FDA Received | 12/31/2014 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|