Brand Name | MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT |
Type of Device | 890.3800 |
Manufacturer (Section D) |
C.T.M. SHANGHAI |
1158 yuan qu road |
anting town |
shanghai 2018 05 |
CH 201805 |
|
MDR Report Key | 4140881 |
MDR Text Key | 4795123 |
Report Number | 1531186-2014-04696 |
Device Sequence Number | 1 |
Product Code |
INI
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Invalid Data |
Reporter Occupation |
Patient
|
Type of Report
| Initial |
Report Date |
10/03/2014,09/17/2014 |
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 | L-3XB |
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 | 10/03/2014 |
Distributor Facility Aware Date | 09/17/2014 |
Device Age | 4 YR |
Date Report to Manufacturer | 10/03/2014 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 10/03/2014 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|