Brand Name | MCKESSON |
Type of Device | EPIDURAL NEEDLE |
Manufacturer (Section D) |
DR. JAPAN CO., LTD. |
4-15-1 nagano |
gyoda city, saitama 361-0 |
JA 361-0 |
|
MDR Report Key | 12502006 |
MDR Text Key | 272511791 |
Report Number | 1058382-2021-00001 |
Device Sequence Number | 1 |
Product Code |
BSP
|
UDI-Device Identifier | 10612479201689 |
UDI-Public | 10612479201689 |
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Distributor
|
Type of Report
| Initial |
Report Date |
09/14/2021 |
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? |
No
|
Device Operator |
Health Professional
|
Device Model Number | 3076V2 |
Device Catalogue Number | TU18G350 |
Device Lot Number | 2003562 |
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
No
|
Distributor Facility Aware Date | 09/01/2021 |
Device Age | 9 MO |
Date Report to Manufacturer | 09/14/2021 |
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 09/20/2021 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|