Brand Name | ROLLATOR ADULT RED 9153641186 |
Type of Device | WALKER, MECHANICAL |
Manufacturer (Section D) |
|
Manufacturer (Section G) |
|
Manufacturer Contact |
kevin
guyton
|
one invacare way |
elyria, OH 44035
|
8003336900
|
|
MDR Report Key | 4956236 |
MDR Text Key | 6251456 |
Report Number | 1525712-2015-04077 |
Device Sequence Number | 1 |
Product Code |
ITJ
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Consumer |
Reporter Occupation |
Patient
|
Type of Report
| Initial |
Report Date |
07/07/2015 |
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 |
Lay User/Patient
|
Device Model Number | UNKNOWN |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
07/07/2015
|
Initial Date FDA Received | 07/31/2015 |
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;
|
|
|