Brand Name | FEMORAL CANAL BRUSH |
Type of Device | LAVAGE, JET |
Manufacturer (Section D) |
STRYKER INSTRUMENTS-PUERTO RICO |
las palmas industrial park |
highway #3, km 130.2 |
arroyo 00615 |
|
Manufacturer (Section G) |
STRYKER INSTRUMENTS-PUERTO RICO |
las palmas industrial park |
highway #3, km 130.2 |
arroyo 00615 |
|
Manufacturer Contact |
casey
metzger
|
4100 east milham avenue |
kalamazoo, MI 49001
|
2693237700
|
|
MDR Report Key | 5345042 |
MDR Text Key | 35088465 |
Report Number | 0001811755-2016-00010 |
Device Sequence Number | 1 |
Product Code |
FQH
|
Combination Product (y/n) | N |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional |
Reporter Occupation |
Nurse
|
Type of Report
| Initial,Followup |
Report Date |
12/09/2015 |
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 Catalogue Number | 0210004000 |
Device Lot Number | 14310012 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 01/07/2016 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
12/09/2015 |
Initial Date FDA Received | 01/05/2016 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 02/18/2016
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 11/06/2014 |
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 |
|
|