Brand Name | SURGPN,ON-Q-TBLOC,CENBS,-,3.5 IN,10 |
Type of Device | REGIONAL ANESTHESIA |
Manufacturer (Section D) |
HALYARD - IRVINE |
43 discovery |
suite 100 |
irvine CA 92618 |
|
Manufacturer (Section G) |
AVENT S DE RL DE CV |
ave noruega edificio d-1b |
fraccionamiento rubio |
tijuana, b.c. 22116 |
MX
22116
|
|
Manufacturer Contact |
lisa
clark
|
5405 windward parkway |
alpharetta, GA 30004
|
4704485444
|
|
MDR Report Key | 5536934 |
MDR Text Key | 41719973 |
Report Number | 2026095-2016-00024 |
Device Sequence Number | 1 |
Product Code |
CAZ
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | PK111355 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Nurse
|
Type of Report
| Initial |
Report Date |
03/04/2016 |
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 |
Nurse
|
Device Model Number | TBT01089T |
Device Catalogue Number | 103272300 |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 03/18/2016 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
03/04/2016 |
Initial Date FDA Received | 03/30/2016 |
Was Device Evaluated by Manufacturer? |
Yes
|
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
|
|