Brand Name | BLADELESS VP 15MM ST W/ FIXATION |
Type of Device | DISPOSABLE SURGICAL ACCESS DEVICE |
Manufacturer (Section D) |
COVIDIEN |
zona franca de san isidro |
carretara san isidro km17 |
santo domingo |
DR |
|
Manufacturer (Section G) |
COVIDIEN |
zona franca de san isidro |
carretara san isidro km17 |
santo domingo |
DR
|
|
Manufacturer Contact |
sharon
murphy
|
60 middletown ave |
north haven, CT 06473
|
2034925267
|
|
MDR Report Key | 4380454 |
MDR Text Key | 13103459 |
Report Number | 9612501-2015-00003 |
Device Sequence Number | 1 |
Product Code |
GCJ
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K081169 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
User Facility |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
12/18/2014 |
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 Model Number | NB15STF |
Device Catalogue Number | NB15STF |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
12/18/2014 |
Initial Date FDA Received | 01/05/2015 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 03/23/2015
|
Was Device Evaluated by Manufacturer? |
Yes
|
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
|
|