Brand Name | 9SL/WD86/78/BH1517/ADULT/15P/AT903/U2222/COM/U240 |
Type of Device | WHEELCHAIR, MECHANICAL |
Manufacturer (Section D) |
INVAMEX |
parque industrial manimex |
reynosa 88780 |
MX 88780 |
|
Manufacturer (Section G) |
INVAMEX |
parque industrial manimex |
|
reynosa 88780 |
MX
88780
|
|
Manufacturer Contact |
kevin
guyton
|
one invacare way |
elyria, OH 44035
|
8003336900
|
|
MDR Report Key | 5744569 |
MDR Text Key | 48029030 |
Report Number | 9616091-2016-00911 |
Device Sequence Number | 1 |
Product Code |
IOR
|
Combination Product (y/n) | N |
Reporter Country Code | US |
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 |
10/12/2011 |
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 | 9SL |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 12/08/2011 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
10/12/2011 |
Initial Date FDA Received | 06/23/2016 |
Was Device Evaluated by Manufacturer? |
Yes
|
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 |