Brand Name | MINI ENDO POCKET BAG 3X4 |
Type of Device | MINI ENDO POCKET BAG 3X4 |
Manufacturer (Section D) |
UNIMAX MEDICAL SYSTEMS, INC. |
8f-2, no. 127 |
lane 235, pao chiao road |
hsin tien city, taipei |
TW |
|
MDR Report Key | 7684834 |
MDR Text Key | 113871212 |
Report Number | 3007216334-2018-00176 |
Device Sequence Number | 1 |
Product Code |
GCJ
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Distributor
|
Type of Report
| Initial |
Report Date |
07/12/2018,07/13/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 07/13/2018 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
No Information
|
Device Catalogue Number | SB534 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 07/05/2018 |
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 07/12/2018 |
Distributor Facility Aware Date | 07/05/2018 |
Date Report to Manufacturer | 07/12/2018 |
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
|
|