Brand Name | MIDWEST E PLUS 1:5 HIGHSPEED ATTACHMENT |
Type of Device | HANDPIECE, AIR-POWERED, DENTAL |
Manufacturer (Section D) |
DENTSPLY PROFESSIONAL |
901 west oakton st. |
des plaines IL 60018 |
|
Manufacturer (Section G) |
SIRONA DENTAL SYSTEMS GMBH |
fabrikstrasse 31 |
|
bensheim, hessen D-646 25 |
GM
D-64625
|
|
Manufacturer Contact |
helen
lewis
|
221 w. philadelphia st. |
suite 60w |
york, PA 17401
|
7178494229
|
|
MDR Report Key | 7074769 |
MDR Text Key | 93851535 |
Report Number | 1419322-2017-00290 |
Device Sequence Number | 1 |
Product Code |
EFB
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K131319 |
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 |
12/01/2017 |
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 Catalogue Number | 875205 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 11/13/2017 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
11/01/2017 |
Initial Date FDA Received | 12/01/2017 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 03/03/2017 |
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 |