Brand Name | DAILY ACTIVITY ASSIST DEVICES |
Type of Device | 890.5050 |
Manufacturer (Section D) |
INVAMEX |
parque industrial manimex |
reynosa 8878 0 |
MX 88780 |
|
Manufacturer (Section G) |
INVAMEX |
parque industrial manimex |
|
reynosa 8878 0 |
MX
88780
|
|
Manufacturer Contact |
gregory
stevens
|
one invacare way |
elyria, OH 44035
|
8003336900
|
|
MDR Report Key | 3686289 |
MDR Text Key | 4295743 |
Report Number | 9616091-2014-00410 |
Device Sequence Number | 1 |
Product Code |
IKX
|
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 Family Member or Friend
|
Type of Report
| Initial |
Report Date |
02/17/2014 |
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 | 9981 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
02/17/2014
|
Initial Date FDA Received | 03/18/2014 |
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;
|
Patient Age | 77 |
Patient Weight | 64 |