Brand Name | NEXSITE HD STEPPED TIP |
Type of Device | HEMODIALYSIS CATHETER |
Manufacturer (Section D) |
MARVAO MEDICAL |
innovation in business centre |
gmit, dublin road |
galway, H91 D CH9 |
EI H91 DCH9 |
|
Manufacturer Contact |
fiona
geraghty
|
innovation in business centre, |
gmit, dublin road |
galway, galway H91 D-CH 9
|
EI
H91 DCH 9
|
91759301
|
|
MDR Report Key | 6050147 |
MDR Text Key | 58135337 |
Report Number | 3008110587-2016-00032 |
Device Sequence Number | 1 |
Product Code |
MSD
|
UDI-Device Identifier | 05391525640020 |
UDI-Public | (01)05391525640020(17)170201(10)43335 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K121933 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
study |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
10/04/2016 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 10/24/2016 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Physician
|
Device Expiration Date | 02/01/2017 |
Device Catalogue Number | NEXHD1552801 |
Device Lot Number | 43335 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 10/04/2016 |
Date Device Manufactured | 02/05/2016 |
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 Outcome(s) |
Required Intervention;
|
Patient Age | 46 YR |
Patient Weight | 67 |
|
|