Brand Name | 100%SILICONE 2WAY PED 3 CC |
Type of Device | FOLEY CATHETER |
Manufacturer (Section D) |
TELEFLEX MEDICAL |
perak, west malaysia |
|
Manufacturer (Section G) |
TELEFLEX MEDICAL |
po box 28, kamunting industrial estate |
|
perak, west malaysia 3460 0 |
MY
34600
|
|
Manufacturer Contact |
jasmine
brown
|
3015 carrington mill blvd |
morrisville, NC 27560
|
9193614124
|
|
MDR Report Key | 4913107 |
MDR Text Key | 15907199 |
Report Number | 8040412-2015-00158 |
Device Sequence Number | 1 |
Product Code |
FGH
|
Combination Product (y/n) | N |
Reporter Country Code | FR |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,User Facility,Company Representative |
Reporter Occupation |
Nurse
|
Type of Report
| Initial,Followup |
Report Date |
06/17/2015 |
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? |
No
|
Device Operator |
Health Professional
|
Device Catalogue Number | 170003100 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 07/14/2015 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
08/03/2015 |
Initial Date FDA Received | 07/14/2015 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 08/04/2015
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Patient Sequence Number | 1 |
|
|