Brand Name | VDW SILVER RECIPROCATING MOTOR |
Type of Device | CONTROLLER, FOOT, HANDPIECE AND CORD |
Manufacturer (Section D) |
DENTSPLY VDW GMBH |
bayerwaldstrasse 15 |
munich, 81737 |
GM 81737 |
|
Manufacturer (Section G) |
ADVANCED TECHNOLOGY RESEARCH (A.T.R.) S.R.L. |
via san donato 1 |
|
pistoia, 51100 |
IT
51100
|
|
Manufacturer Contact |
karl
nittinger
|
221 w. philadelphia st. |
suite 60w |
york, PA 17401
|
7178494424
|
|
MDR Report Key | 10524427 |
MDR Text Key | 207033524 |
Report Number | 9611053-2020-00242 |
Device Sequence Number | 1 |
Product Code |
EBW
|
Combination Product (y/n) | N |
Reporter Country Code | GM |
PMA/PMN Number | NA |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional |
Reporter Occupation |
Dentist
|
Type of Report
| Initial |
Report Date |
09/11/2020 |
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 | V041163000000 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
08/13/2020
|
Initial Date FDA Received | 09/11/2020 |
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 |
Unknown
|
Patient Sequence Number | 1 |