Brand Name | TITANIUM LIGATING CLIPS |
Type of Device | CLIP, IMPLANTABLE |
Manufacturer (Section D) |
TELEFLEX MEDICAL |
morrisville NC |
|
Manufacturer (Section G) |
TELEFLEX MEDICAL |
rancho el descanso |
|
tecate 21478 |
MX
21478
|
|
Manufacturer Contact |
effie
jefferson
|
3015 carrington mill blvd |
morrisville 27560
|
9194332672
|
|
MDR Report Key | 16428874 |
MDR Text Key | 310077357 |
Report Number | 3003898360-2023-00343 |
Device Sequence Number | 1 |
Product Code |
FZP
|
UDI-Device Identifier | 34026704624790 |
UDI-Public | 34026704624790 |
Combination Product (y/n) | N |
Reporter Country Code | CA |
PMA/PMN Number | K132658 |
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 |
02/17/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | 002204 |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
02/17/2023
|
Initial Date FDA Received | 02/23/2023 |
Supplement Dates Manufacturer Received | 03/01/2023
|
Supplement Dates FDA Received | 04/07/2023
|
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 |
A
|
Patient Sequence Number | 1 |
Treatment | NONE REPORTED.; NONE REPORTED. |
Patient Outcome(s) |
Life Threatening;
Required Intervention;
Hospitalization;
|