MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-03-11 for VDW SILVER RECIPROCATING MOTOR V041163000000 manufactured by Dentsply Vdw Gmbh.
Report Number | 9611053-2020-00056 |
MDR Report Key | 9820827 |
Report Source | FOREIGN,HEALTH PROFESSIONAL |
Date Received | 2020-03-11 |
Date of Report | 2020-03-07 |
Date Added to Maude | 2020-03-11 |
Event Key | 0 |
Report Source Code | Manufacturer report |
Manufacturer Link | Y |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 3 |
Reporter Occupation | DENTIST |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Contact | MR. KARL NITTINGER |
Manufacturer Street | 221 W. PHILADELPHIA ST. SUITE 60W |
Manufacturer City | YORK, PA |
Manufacturer Country | US |
Manufacturer Phone | 8494424 |
Manufacturer G1 | ADVANCED TECHNOLOGY RESEARCH (A.T.R.) S.R.L. |
Manufacturer Street | VIA SAN DONATO 1 |
Manufacturer City | PISTOIA, 51100 |
Manufacturer Country | IT |
Manufacturer Postal Code | 51100 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | VDW SILVER RECIPROCATING MOTOR |
Generic Name | CONTROLLER, FOOT, HANDPIECE AND CORD |
Product Code | EBW |
Date Received | 2020-03-11 |
Returned To Mfg | 2020-02-27 |
Model Number | NA |
Catalog Number | V041163000000 |
Lot Number | NA |
Operator | HEALTH PROFESSIONAL |
Device Availability | R |
Device Eval'ed by Mfgr | Y |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | DENTSPLY VDW GMBH |
Manufacturer Address | BAYERWALDSTRASSE 15 MUNICH, 81737 GM 81737 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2020-03-11 |