Brand Name | TYSHAK II |
Type of Device | PERCUTANEOUS VALVULOPLASTY CATHETER |
Manufacturer (Section D) |
NUMED CANADA, INC. |
45 second st. west |
cornwall, ontario K6J 1G3 |
CA K6J 1G3 |
|
Manufacturer (Section G) |
NUMED CANADA, INC. |
45 second st. |
|
cornwall, ontario K6J 1G3 |
CA
K6J 1G3
|
|
Manufacturer Contact |
nichelle
laflesh
|
2880 main st |
hopkinton, NY 12965
|
3153284491
|
|
MDR Report Key | 4732985 |
MDR Text Key | 5749352 |
Report Number | 9618000-2015-00001 |
Device Sequence Number | 1 |
Product Code |
LIT
|
Combination Product (y/n) | N |
Reporter Country Code | GM |
PMA/PMN Number | K003052 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Distributor |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
04/24/2015 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 04/27/2015 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Other
|
Device Expiration Date | 03/31/2017 |
Device Model Number | 105 |
Device Catalogue Number | PDC542 |
Device Lot Number | TH-17400 |
Was Device Available for Evaluation? |
Yes
|
Date Returned to Manufacturer | 04/10/2015 |
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 03/30/2015 |
Was Device Evaluated by Manufacturer? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
|
|