Brand Name | HANAROSTENT ESO TTS FC 20 DM 15CM 230 |
Type of Device | PROSTHESIS, ESOPHAGEAL |
Manufacturer (Section D) |
M.I.TECH CO., LTD. |
174, habuk2-gil, jinwi-myeon |
pyeongtaek, gyeonggi 17706 |
KS 17706 |
|
MDR Report Key | 17412986 |
MDR Text Key | 319935493 |
Report Number | 2429304-2023-00248 |
Device Sequence Number | 1 |
Product Code |
ESW
|
UDI-Device Identifier | 08806367088598 |
UDI-Public | 08806367088598 |
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Distributor
|
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
07/21/2021,07/28/2023 |
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? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | ECBA-20-150-230 |
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
Yes
|
Distributor Facility Aware Date | 07/21/2021 |
Event Location |
Hospital
|
Date Report to Manufacturer | 07/21/2021 |
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 07/28/2023 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
|
|