Brand Name | DOSI-FUSER |
Type of Device | ELASTOMERIC INFUSION PUMP |
Manufacturer (Section D) |
LEVENTON S.A.U. |
esteve sesrovires, barcelona |
SP |
|
Manufacturer Contact |
david
salvatierra, qlty mgr
|
c/newton 18-24, poligono |
industrial sesrovires, sant |
esteve sesrovires, barcelona 08635
|
SP
08635
|
38176300
|
|
MDR Report Key | 4975974 |
MDR Text Key | 22380706 |
Report Number | 9611707-2015-00004 |
Device Sequence Number | 1 |
Product Code |
MEB
|
Combination Product (y/n) | N |
PMA/PMN Number | K040752 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
other |
Remedial Action |
Inspection |
Report Date |
04/14/2015 |
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 Expiration Date | 10/31/2016 |
Device Model Number | L25915-250D2-USA |
Device Catalogue Number | L25915-250D2-USA |
Device Lot Number | 141727L |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 08/04/2015 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 10/01/2014 |
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 |
|
|