Brand Name | SMARTEZ PUMP |
Type of Device | ELASTOMERIC INFUSION PUMP |
Manufacturer (Section D) |
EPIC INTERNATIONAL (THAILAND) CO., LTD. |
hemaraj eastern seaboard indus |
500/73 moo 2, tasit |
pluak daeng rayong, 21140 |
TH 21140 |
|
Manufacturer (Section G) |
EPIC INTERNATIONAL (THAILAND) CO., LTD |
hemaraj eastern seaboard indus |
500/73 moo 2, tasit |
pluak daeng rayong, 21140 |
TH
21140
|
|
Manufacturer Contact |
david
lennarz
|
144 research dr |
hampton |
va
|
2240177
|
|
MDR Report Key | 9801648 |
MDR Text Key | 221858255 |
Report Number | 3012429465-2020-00002 |
Device Sequence Number | 1 |
Product Code |
MEB
|
UDI-Device Identifier | 18859299104048 |
UDI-Public | (01)18859299104048(10)C8M65(17)211028(11)181128(241)SE0005-270C |
Combination Product (y/n) | N |
PMA/PMN Number | K151650 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional,u |
Type of Report
| Initial |
Report Date |
03/05/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 10/28/2021 |
Device Model Number | 484041 |
Device Lot Number | C8M65 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 08/13/2019 |
Initial Date Manufacturer Received |
08/05/2019
|
Initial Date FDA Received | 03/06/2020 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 11/28/2018 |
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 |