Brand Name | VISISTAT 35W NON-STERILE |
Type of Device | STAPLER |
Manufacturer (Section D) |
|
Manufacturer Contact |
jasmine
brown
|
4024 stirrup creed dr. |
suite 720 |
durham, NC 27703
|
9193614124
|
|
MDR Report Key | 3997810 |
MDR Text Key | 16945233 |
Report Number | 3003898360-2014-00453 |
Device Sequence Number | 1 |
Product Code |
GAG
|
Combination Product (y/n) | N |
Reporter Country Code | EZ |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,User Facility,Company Representative,Distributor |
Reporter Occupation |
Not Applicable
|
Type of Report
| Initial |
Report Date |
06/10/2014 |
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? |
No
|
Device Operator |
Health Professional
|
Device Catalogue Number | 528236 |
Device Lot Number | 01B1300360 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
06/10/2014
|
Initial Date FDA Received | 07/01/2014 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 02/01/2013 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
|
|