Brand Name | 3M ESPE ELIIPAR DEEPCURE-S LED CURING LIGHT |
Type of Device | ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION |
Manufacturer (Section D) |
3M DEUTSCHLAND GMBH |
carl-schurz-strasse 1 |
neuss, 41453 |
GM 41453 |
|
Manufacturer (Section G) |
3M DEUTSCHLAND GMBH-SEEFELD |
espe platz |
|
seefeld, 82229 |
GM
82229
|
|
Manufacturer Contact |
thomas
meindl
|
carl-schurz-strasse 1 |
neuss, 41453
|
GM
41453
|
|
MDR Report Key | 6723564 |
MDR Text Key | 80379718 |
Report Number | 9611385-2017-00009 |
Device Sequence Number | 1 |
Product Code |
EBZ
|
UDI-Device Identifier | J001702011438670 |
UDI-Public | +J001702011438670 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K011154 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional |
Reporter Occupation |
Dentist
|
Type of Report
| Initial |
Report Date |
07/07/2017 |
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 Model Number | 76976 |
Device Catalogue Number | 76976 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
07/07/2017 |
Initial Date FDA Received | 07/18/2017 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
Required Intervention;
|
Patient Age | 73 YR |