Brand Name | ENDURANCE PYRAMID CANE |
Type of Device | PYRAMID CANE |
Manufacturer (Section D) |
FOSHAN R. POON MEDICAL PRODUCTS CO., LTD |
new city district, donzao, nanhai, fosha 5282 16 |
CH 528216 |
|
Manufacturer (Section G) |
ESSENTIAL MEDICAL SUPPLY, INC. |
6420 hazeltine national dr. |
|
orlando FL 32822 |
|
Manufacturer Contact |
|
6420 hazeltine national dr. |
orlando, FL 32822
|
|
MDR Report Key | 4827653 |
MDR Text Key | 5843345 |
Report Number | 1056127-2015-00013 |
Device Sequence Number | 1 |
Product Code |
KHY
|
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Distributor
|
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
05/18/2015 |
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 | RPM70020 |
Device Catalogue Number | W1300 |
Was Device Available for Evaluation? |
Yes
|
Date Returned to Manufacturer | 06/05/2015 |
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 06/05/2015 |
Distributor Facility Aware Date | 05/18/2015 |
Device Age | 2 YR |
Event Location |
Other
|
Date Report to Manufacturer | 06/04/2015 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 06/05/2015 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|