Brand Name | TREX2/WD86/ADULT/28/BH16/1255/U2222C/COM/U550 9153637774 |
Type of Device | WHEELCHAIR, MECHANICAL |
Manufacturer (Section D) |
|
MDR Report Key | 4395299 |
MDR Text Key | 17293329 |
Report Number | 1531186-2015-00088 |
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 |
Distributor
|
Source Type |
Invalid Data |
Reporter Occupation |
Medical Equipment Company Technician/Representative
|
Type of Report
| Initial |
Report Date |
01/06/2015,12/16/2014 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 01/08/2015 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Model Number | TREX28R |
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 | 01/06/2015 |
Distributor Facility Aware Date | 12/16/2014 |
Device Age | 57 MO |
Date Report to Manufacturer | 01/06/2015 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|