Brand Name | MCKESSON |
Type of Device | INSULIN SYRINGE |
Manufacturer (Section D) |
JIANGSU CAINA MEDICAL CO., LTD. |
no 23, huanxi rd |
zhutang town |
jiangyin, jiangsu 21441 5 |
CH 214415 |
|
Manufacturer (Section G) |
JIANGSU CAINA MEDICAL CO., LTD. |
no 23, huanxi rd |
zhutang town |
jiangyin, jiangsu 21441 5 |
CH
214415
|
|
Manufacturer Contact |
camel
zhou
|
no 23, huanxi rd |
zhutang town |
jiangyin, jiangsu 21441-5
|
CH
214415
|
|
MDR Report Key | 19102919 |
MDR Text Key | 340805817 |
Report Number | 3005670221-2024-00089 |
Device Sequence Number | 1 |
Product Code |
FMF
|
Combination Product (y/n) | N |
Reporter Country Code | CH |
PMA/PMN Number | K151949 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Distributor |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
04/14/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 04/14/2024 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Catalogue Number | 102-SN310C31516P |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 05/25/2022 |
Was Device Evaluated by Manufacturer? |
No
|
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) |
Other;
|
|
|