Brand Name | WECKSTAT STAPLE EXTRACTOR 12/BOX |
Type of Device | SKIN STAPLER |
Manufacturer (Section D) |
|
Manufacturer Contact |
jasmine
brown, regulatory affairs
|
po box 12600 |
rtp, NC 27709
|
9193614124
|
|
MDR Report Key | 3916702 |
MDR Text Key | 4513579 |
Report Number | 3003898360-2014-00134 |
Device Sequence Number | 1 |
Product Code |
GAG
|
Combination Product (y/n) | N |
Reporter Country Code | GM |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
User Facility,Company Representative |
Reporter Occupation |
Not Applicable
|
Type of Report
| Initial |
Report Date |
02/13/2014 |
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 |
Other
|
Device Catalogue Number | 525980 |
Device Lot Number | 01B1300180 |
Was Device Available for Evaluation? |
Yes
|
Date Returned to Manufacturer | 02/25/2014 |
Initial Date Manufacturer Received |
02/13/2014 |
Initial Date FDA Received | 03/07/2014 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 02/01/2013 |
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
|
|