Brand Name | PALINDROME 55/72 KIT W/ SLOT |
Type of Device | DIALYSIS CATHETER |
Manufacturer (Section D) |
COVIDIEN |
5439 state route 40 |
argyle NY 12809 |
|
Manufacturer (Section G) |
COVIDIEN |
5439 state route 40 |
|
argyle NY 12809 |
|
Manufacturer Contact |
lawrence
rock
|
15 hampshire st |
mansfield, MA 02048
|
5082616625
|
|
MDR Report Key | 3856068 |
MDR Text Key | 4621624 |
Report Number | 1317749-2014-00168 |
Device Sequence Number | 1 |
Product Code |
MPB
|
Combination Product (y/n) | N |
Reporter Country Code | MX |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,User Facility |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
03/24/2014 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/27/2014 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 8888145018 |
Device Catalogue Number | 8888145018 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 03/24/2014 |
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Age | 55 YR |
|
|