Brand Name | MAHURKAR |
Type of Device | CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED |
Manufacturer (Section D) |
COVIDIEN MFG SOLUTIONS S.A. |
edificio b20, calle #2 |
alajuela 20101 |
|
Manufacturer (Section G) |
COVIDIEN MFG SOLUTIONS S.A. |
edificio b20, calle #2 |
|
alajuela 20101 |
|
Manufacturer Contact |
lisa
hernandez
|
15 hampshire street |
mansfield, MA 02048
|
5084524938
|
|
MDR Report Key | 7156708 |
MDR Text Key | 96219173 |
Report Number | 3009211636-2018-00001 |
Device Sequence Number | 1 |
Product Code |
NIE
|
Combination Product (y/n) | N |
Reporter Country Code | BR |
PMA/PMN Number | K020089 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional,u |
Reporter Occupation |
Health Professional
|
Type of Report
| Initial,Followup,Followup |
Report Date |
09/13/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 01/02/2018 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 08/09/2021 |
Device Model Number | 8888345629 |
Device Catalogue Number | 8888345629 |
Device Lot Number | 1625300122 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 08/02/2018 |
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 08/24/2018 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 09/09/2016 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Age | 85 YR |
|
|