Brand Name | OBTURA HANDPIECE, NEW MAX |
Type of Device | PLUGGER, ROOT CANAL, ENDODONTIC |
Manufacturer (Section D) |
YOUNG OS, LLC |
2260 wendt st |
algonquin IL 60102 |
|
Manufacturer (Section G) |
YOUNG OS, LLC |
2260 wendt st |
|
algonquin IL 60102 |
|
Manufacturer Contact |
asmita
patel
|
2260 wendt st |
algonquin, IL 60102
|
8474585642
|
|
MDR Report Key | 5809751 |
MDR Text Key | 50077164 |
Report Number | 1926480-2016-00001 |
Device Sequence Number | 1 |
Product Code |
EKR
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K042828 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative |
Reporter Occupation |
Service and Testing Personnel
|
Type of Report
| Initial |
Report Date |
07/13/2016 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 07/20/2016 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
No Information
|
Device Model Number | OBTURA III MAX |
Device Catalogue Number | 823-810 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 06/08/2016 |
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 06/08/2016 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 05/26/2011 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |