Brand Name | RELIEVA SPIN SINUPLASTY SYSTEM |
Type of Device | INSTRUMENT, ENT MANUAL SURGICAL |
Manufacturer (Section D) |
ACCLARENT |
1525-b o brien dr |
menlo park CA |
|
Manufacturer Contact |
izabel
nielson
|
1525-b o brien dr |
menlo park, CA 94025
|
|
MDR Report Key | 4739742 |
MDR Text Key | 21472804 |
Report Number | 3005172759-2015-00008 |
Device Sequence Number | 1 |
Product Code |
LRC
|
Combination Product (y/n) | N |
PMA/PMN Number | K111875 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Invalid Data |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
04/30/2015 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Other
|
Device Expiration Date | 12/12/2017 |
Device Catalogue Number | RS0616M |
Device Lot Number | 141212A-CM |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 04/30/2015 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 12/18/2014 |
Is the Device Single Use? |
Yes
|
Patient Sequence Number | 1 |
Patient Age | 68 |
|
|