Brand Name | PILLING AORTIC PUNCH STD TIP 5.0 |
Type of Device | AORTIC PUNCH |
Manufacturer (Section D) |
TELEFLEX |
nuevo laredo, tamaulipas |
MX |
|
Manufacturer (Section G) |
TELEFLEX MEDICAL |
ave. industrias no.5954 |
parque industrial finsa |
nuevo laredo, tamaulipas |
MX
|
|
Manufacturer Contact |
elaine
burkle, rn
|
po box 12600 |
durham, NC 27709
|
9194334957
|
|
MDR Report Key | 3804551 |
MDR Text Key | 4477401 |
Report Number | 3004365956-2014-00182 |
Device Sequence Number | 1 |
Product Code |
DWS
|
Combination Product (y/n) | N |
Reporter Country Code | CA |
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 Health Care Professional
|
Type of Report
| Initial |
Report Date |
03/06/2014 |
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? |
No
|
Device Operator |
Health Professional
|
Device Catalogue Number | 353450 |
Device Lot Number | 02A1301684 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
03/12/2014
|
Initial Date FDA Received | 04/28/2014 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 01/01/2013 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|