Brand Name | MICROPORTABLE 4 WHEEL (BLUE) 9153645579 |
Type of Device | VEHICLE, MOTORIZED 3-WHEELED |
Manufacturer (Section D) |
C.T.M. TAIWAN |
no. 33-12, lin 1 |
chiu tou village |
taoyuan hsien 327 |
TW 327 |
|
MDR Report Key | 4331898 |
MDR Text Key | 17295326 |
Report Number | 1531186-2014-06291 |
Device Sequence Number | 1 |
Product Code |
INI
|
Combination Product (y/n) | N |
Reporter Country Code | CA |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Distributor
|
Source Type |
Invalid Data |
Reporter Occupation |
Medical Equipment Company Technician/Representative
|
Type of Report
| Initial |
Report Date |
12/12/2014,10/29/2014 |
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 | COMET4S |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 12/12/2014 |
Distributor Facility Aware Date | 10/29/2014 |
Device Age | 2 YR |
Date Report to Manufacturer | 12/12/2014 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 12/16/2014 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|