Brand Name | CASTROVIEJO NH 8" TC |
Type of Device | INSTRUMENTS, SURGICAL, CARDIO |
Manufacturer (Section D) |
TELEFLEX MEDICAL |
morrisville NC |
|
Manufacturer (Section G) |
TELEFLEX MEDICAL |
3015 carrington mill blvd |
|
morrisville NC 27560 |
|
Manufacturer Contact |
effie
jefferson
|
3015 carrington mill blvd |
morrisville 27560
|
9194332672
|
|
MDR Report Key | 15142024 |
MDR Text Key | 304801982 |
Report Number | 3011137372-2022-00158 |
Device Sequence Number | 1 |
Product Code |
DWS
|
UDI-Device Identifier | 24026704522129 |
UDI-Public | 24026704522129 |
Combination Product (y/n) | N |
Reporter Country Code | RP |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
07/03/2022 |
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 |
Health Professional
|
Device Model Number | IPN005932 |
Device Catalogue Number | 354965 |
Device Lot Number | J9 |
Was Device Available for Evaluation? |
Yes
|
Initial Date Manufacturer Received |
07/03/2022 |
Initial Date FDA Received | 08/01/2022 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
A
|
Patient Sequence Number | 1 |