Brand Name | PUREGOLD COUDE 2WPTFE 5CC |
Type of Device | FOLEY CATHETER |
Manufacturer (Section D) |
TELEFLEX MEDICAL |
perak, west malaysia |
MY |
|
Manufacturer (Section G) |
TELEFLEX MEDICAL |
p.o. box 28 |
kamunting industrial estate |
perak, west malaysia 3460 0 |
MY
34600
|
|
Manufacturer Contact |
effie
jefferson
|
3015 carrington mill blvd |
morrisville, NC 27560
|
9194332672
|
|
MDR Report Key | 4432421 |
MDR Text Key | 5393612 |
Report Number | 8040412-2015-00005 |
Device Sequence Number | 1 |
Product Code |
EZL
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,User Facility,Company Representative |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
12/19/2014 |
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? |
No
|
Device Operator |
Other
|
Device Catalogue Number | 318116 |
Was Device Available for Evaluation? |
Yes
|
Initial Date Manufacturer Received |
12/18/2014
|
Initial Date FDA Received | 01/16/2015 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Patient Sequence Number | 1 |