Brand Name | SURGPN,5",EXP KT,-,OQ,5 |
Type of Device | CATHETERS |
Manufacturer (Section D) |
HALYARD - IRVINE |
43 discovery |
suite 100 |
irvine CA 92618 |
|
Manufacturer (Section G) |
AVENT S. DE R.L. DE C.V. |
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 | 6031315 |
MDR Text Key | 57558013 |
Report Number | 2026095-2016-00165 |
Device Sequence Number | 1 |
Product Code |
BSO
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | PD024795 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
09/22/2016 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 10/14/2016 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Other Health Care Professional
|
Device Model Number | PM020-A |
Device Catalogue Number | 101353500 |
Device Lot Number | UNKNOWN |
Other Device ID Number | 10680651135350 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 09/22/2016 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|