Brand Name | SMARTEZ ELASTOMERIC INFUSION DEVICE |
Type of Device | PUMP, INFUSION, ELASTOMERIC |
Manufacturer (Section D) |
EPIC INTERNATIONAL (THAILAND) CO., LTD. |
tasit |
pluakdaeng, rayong 2140 TH |
TH 2140 TH |
|
MDR Report Key | 8883469 |
MDR Text Key | 154119881 |
Report Number | MW5088941 |
Device Sequence Number | 1 |
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 |
08/07/2019 |
2 Devices were Involved in the Event: |
1
2
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Model Number | SE0200-100 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 08/09/2019 |
Was Device Evaluated by Manufacturer? |
No Information
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
|
|