Brand Name | CRUTCH |
Type of Device | 890.3150 |
Manufacturer (Section D) |
MAXHEALTH CORP. |
15f-6 no. 81, hsin tai wu rd |
section 1 |
hsi chih, taipei hsien |
TW |
|
MDR Report Key | 3678243 |
MDR Text Key | 4237182 |
Report Number | 1531186-2014-00816 |
Device Sequence Number | 1 |
Product Code |
IPR
|
Combination Product (y/n) | N |
Reporter Country Code | TD |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Invalid Data |
Reporter Occupation |
Medical Equipment Company Technician/Representative
|
Type of Report
| Initial |
Report Date |
03/13/2014,02/12/2014 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/13/2014 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Model Number | 6135 |
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 | 03/13/2014 |
Distributor Facility Aware Date | 02/12/2014 |
Date Report to Manufacturer | 03/13/2014 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|