Brand Name | VISISTAT 35R 6/BOX |
Type of Device | STAPLER |
Manufacturer (Section D) |
|
Manufacturer Contact |
effie
jefferson, rn, regulatory
|
po box 12600 |
durham, NC 27709
|
9194332672
|
|
MDR Report Key | 4163212 |
MDR Text Key | 4766590 |
Report Number | 3003898360-2014-00462 |
Device Sequence Number | 1 |
Product Code |
GAG
|
Combination Product (y/n) | N |
Reporter Country Code | FR |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,User Facility |
Reporter Occupation |
Not Applicable
|
Type of Report
| Initial |
Report Date |
06/20/2014 |
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 | 528135 |
Device Lot Number | 01M1300167 |
Was Device Available for Evaluation? |
Yes
|
Initial Date Manufacturer Received |
06/20/2014
|
Initial Date FDA Received | 07/16/2014 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 12/01/2013 |
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
|
|