Brand Name | TKMD |
Type of Device | SAFETY SYRINGE WITH NEEDLE |
Manufacturer (Section D) |
ANHUI TIANKANG MEDICAL TECHNOLOGY CO., LTD |
no. 288 weiyi road |
economic development zone |
tianchang city, anhul, chn |
CH |
|
Manufacturer (Section G) |
MCKESSON MEDICAL SURGICAL, INC |
1125 sycamore road |
|
manteno IL 60950 |
|
Manufacturer Contact |
jo
silverthorne
|
9954 mayland drive |
richmond, VA 23233
|
8045532278
|
|
MDR Report Key | 12786429 |
MDR Text Key | 281511888 |
Report Number | 3017368639-2021-00180 |
Device Sequence Number | 1 |
Product Code |
MEG
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | UNKNOWN |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
11/09/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | UNKNOWN |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
10/13/2021
|
Initial Date FDA Received | 11/10/2021 |
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;
|
|
|