Brand Name | GLUMA DESENSITIZER |
Type of Device | AGENT, TOOTH BONDING, RESIN |
Manufacturer (Section D) |
HERAEUS KULZER GMBH |
philipp-reis-strasse 8/13 |
wehrheim, D-61 273 |
GM D-61273 |
|
Manufacturer (Section G) |
HERAEUS KULZER GMBH |
philipp-reis-strasse 8/13 |
|
wehrheim, D-61 273 |
GM
D-61273
|
|
Manufacturer Contact |
rita
rogers
|
300 heraeus way |
south bend, IN 46614
|
5742995409
|
|
MDR Report Key | 4062841 |
MDR Text Key | 4899018 |
Report Number | 9610902-2014-00044 |
Device Sequence Number | 1 |
Product Code |
KLE
|
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K962812 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Company Representative |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
02/14/2014 |
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 |
Dentist
|
Device Catalogue Number | 65872354 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Distributor Facility Aware Date | 08/21/2014 |
Initial Date Manufacturer Received |
08/21/2014
|
Initial Date FDA Received | 09/05/2014 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 30 YR |
|
|