Brand Name | UNIEVER DISPOSABLE EPIDURAL ANESTHESIA NEEDLE |
Type of Device | EPIDURAL NEEDLE |
Manufacturer (Section D) |
UNISIS CORP. |
taito-ku, tokyo |
JA |
|
Manufacturer (Section G) |
SAITAMA FACTORY |
2675-1 nishikata |
|
koshigaya-shi, saitama 343- 0822 |
JA
343-0822
|
|
Manufacturer Contact |
|
2623-1 nishikata |
arakawa-ku |
koshigaya-shi, saitama 343-0-822
|
89908250
|
|
MDR Report Key | 3918320 |
MDR Text Key | 4489142 |
Report Number | 9681709-2014-00007 |
Device Sequence Number | 1 |
Product Code |
BSP
|
Combination Product (y/n) | N |
Reporter Country Code | BR |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,User Facility,Distributor |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
05/19/2014 |
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 Expiration Date | 04/30/2016 |
Device Catalogue Number | 111113 |
Device Lot Number | 12E001 |
Was Device Available for Evaluation? |
Yes
|
Date Returned to Manufacturer | 06/04/2014 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
05/19/2014 |
Initial Date FDA Received | 06/05/2014 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 05/01/2012 |
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
|
|