Brand Name | SUPERCATH 5 |
Type of Device | CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS |
Manufacturer (Section D) |
TOGO MEDIKIT CO.LTD. |
17148-6 aza kamekawa |
oaza hichiya |
hyuga city, miyazaki prefecture 883-0 062 |
JA 883-0062 |
|
Manufacturer (Section G) |
TOGO MEDIKIT CO.LTD. |
17148-6 aza kamekawa |
oaza hichiya |
hyuga city, miyazaki prefecture 883-0 062 |
JA
883-0062
|
|
Manufacturer Contact |
yashaswini
patwardhan
|
747 n. milwaukee ave |
suite 102 |
libertyville, IL 60048
|
|
MDR Report Key | 6598683 |
MDR Text Key | 76210474 |
Report Number | 9612126-2017-00003 |
Device Sequence Number | 1 |
Product Code |
FOZ
|
Combination Product (y/n) | N |
Reporter Country Code | TW |
PMA/PMN Number | K140419 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,foreign,health pr |
Reporter Occupation |
Nurse
|
Type of Report
| Initial |
Report Date |
05/02/2017 |
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 Catalogue Number | SP200-01 |
Device Lot Number | 17B15A9 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
05/01/2017 |
Initial Date FDA Received | 05/30/2017 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 40 YR |
|
|