Brand Name | MYON SWINGAWAY WHEELCHAIR |
Type of Device | WHEELCHAIR, MECHANICAL |
Manufacturer (Section D) |
INVAMEX MANUFACTURING |
102 parque industrial manimex |
reynosa 88780 |
MX 88780 |
|
Manufacturer (Section G) |
INVAMEX MANUFACTURING |
102 parque industrial manimex |
|
reynosa, tamaulipas 88780 |
MX
88780
|
|
Manufacturer Contact |
jason
fiest
|
one invacare way |
elyria, OH 44035
|
8003336900
|
|
MDR Report Key | 9494571 |
MDR Text Key | 171967116 |
Report Number | 9616091-2019-00032 |
Device Sequence Number | 1 |
Product Code |
IOR
|
Combination Product (y/n) | N |
Reporter Country Code | UK |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
other |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
11/22/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Lay User/Patient
|
Device Model Number | NA:MYON |
Device Catalogue Number | MYON |
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
11/22/2019 |
Initial Date FDA Received | 12/19/2019 |
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) |
Death;
Hospitalization;
Other;
|