Brand Name | SMARTEZ PUMP |
Type of Device | PUMP, INFUSION, ELASTOMERIC |
Manufacturer (Section D) |
EPIC INTERNATIONAL (THAILAND) CO., LTD. |
tasit |
pluakdaeng, rayong 21140 TH |
TH 21140 TH |
|
MDR Report Key | 8658374 |
MDR Text Key | 146923638 |
Report Number | MW5087027 |
Device Sequence Number | 4 |
Product Code |
MEB
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Voluntary
|
Reporter Occupation |
Pharmacist
|
Type of Report
| Initial |
Report Date |
05/29/2019 |
15 Devices were Involved in the Event: |
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
No Information
|
Device Model Number | SE0200-100 |
Device Lot Number | S8A28 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 05/30/2019 |
Was Device Evaluated by Manufacturer? |
No Information
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
|
|