Brand Name | PU MDP-40K DISP PUNCH 4.0MM |
Type of Device | INSTRUMENTS, SURGICAL, CARDIOV |
Manufacturer (Section D) |
TELEFLEX MEDICAL |
morrisville NC |
|
Manufacturer (Section G) |
TELEFLEX MEDICAL |
parque industrial finsa |
|
nuevo laredo 88275 |
MX
88275
|
|
Manufacturer Contact |
effie
jefferson
|
3015 carrington mill blvd |
morrisville 27560
|
9194332672
|
|
MDR Report Key | 15749506 |
MDR Text Key | 303220703 |
Report Number | 3004365956-2022-00092 |
Device Sequence Number | 1 |
Product Code |
DWS
|
UDI-Device Identifier | 14026704735454 |
UDI-Public | 14026704735454 |
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,Company Representative |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
10/18/2022 |
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 Model Number | IPN917586 |
Device Catalogue Number | MDP-40K |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
10/18/2022 |
Initial Date FDA Received | 11/07/2022 |
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 |
Patient Outcome(s) |
Required Intervention;
|