Brand Name | ICAST COVERED STENT |
Type of Device | PROSTHESIS, TRACHEAL, EXPANDABLE |
Manufacturer (Section D) |
ATRIUM MEDICAL CORPORATION |
40 continental blvd |
merrimack NH 03054 |
|
MDR Report Key | 9342737 |
MDR Text Key | 175270963 |
Report Number | 3011175548-2019-01183 |
Device Sequence Number | 1 |
Product Code |
JCT
|
UDI-Device Identifier | 00650862854459 |
UDI-Public | 00650862854459 |
Combination Product (y/n) | N |
PMA/PMN Number | K050814 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Type of Report
| Initial,Followup,Followup |
Report Date |
11/19/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 11/19/2019 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 07/09/2022 |
Device Model Number | 85445 |
Device Catalogue Number | 85445 |
Device Lot Number | 448359 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 12/09/2019 |
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 02/01/2021 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 73 YR |
|
|