Brand Name | RELIEVA SPIN SINUPLASTY SYSTEM |
Type of Device | INSTRUMENT, ENT MANUAL SURGICAL |
Manufacturer (Section D) |
ACCLARENT, INC. |
33 technology drive |
irvine CA |
|
Manufacturer Contact |
joaquin
kurz
|
33 technology drive |
irvine, CA 92618
|
9497899383
|
|
MDR Report Key | 5568874 |
MDR Text Key | 42373234 |
Report Number | 3005172759-2016-00007 |
Device Sequence Number | 1 |
Product Code |
LRC
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Health Professional
|
Type of Report
| Initial |
Report Date |
03/25/2016 |
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 |
Health Professional
|
Device Catalogue Number | RS0616MFS |
Device Lot Number | 150701B-CM |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 04/11/2016 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Hospitalization;
Other;
|