Brand Name | BRILLANT 2-W SILICONE FOLEY, CYLINDRICAL |
Type of Device | CATHETER, RETENTION TYPE, BALLOON |
Manufacturer (Section D) |
TELEFLEX MEDICAL SDN. BHD. |
perak, west malaysia |
|
Manufacturer (Section G) |
TELEFLEX MEDICAL SDN. BHD. |
lot no : pt2577 jalen perusahaan |
4 kamunting industrial estate |
perak, west malaysia 34600 |
MY
34600
|
|
Manufacturer Contact |
katharine
tarpley
|
3015 carrington mill blvd |
morrisville, NC 27560
|
|
MDR Report Key | 17342149 |
MDR Text Key | 319199161 |
Report Number | 8040412-2023-00290 |
Device Sequence Number | 1 |
Product Code |
EZL
|
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 |
Other
|
Type of Report
| Initial,Followup |
Report Date |
06/26/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 07/18/2023 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | 170605-000160 |
Device Lot Number | KME22K0825 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 08/11/2023 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
|
|