Brand Name | RELIEVA SPINPLUS |
Type of Device | INSTRUMENT, ENT MANUAL SURGICAL |
Manufacturer (Section D) |
ACCLARENT, INC. |
33 technology drive |
irvine CA 92618 |
|
MDR Report Key | 6837460 |
MDR Text Key | 84326809 |
Report Number | 6837460 |
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 |
User Facility
|
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
08/29/2017 |
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 Expiration Date | 11/30/2018 |
Device Model Number | RSP0616MFS |
Device Catalogue Number | RSP0616MFS |
Device Lot Number | 161130A-PC |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 08/29/2017 |
Device Age | 1 DY |
Event Location |
Hospital
|
Date Report to Manufacturer | 08/29/2017 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 09/01/2017 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Age | 47 YR |
|
|