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 2019-12-31 for EDDY IRRIGATION TIP V041441000000 manufactured by Dentsply Vdw Gmbh.
Report Number | 9611053-2019-00457 |
MDR Report Key | 9535247 |
Report Source | FOREIGN,HEALTH PROFESSIONAL |
Date Received | 2019-12-31 |
Date of Report | 2020-03-30 |
Date Mfgr Received | 2019-11-21 |
Date Added to Maude | 2019-12-31 |
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 17401 |
Manufacturer Country | US |
Manufacturer Postal | 17401 |
Manufacturer Phone | 7178494424 |
Manufacturer G1 | DENTSPLY VDW GMBH |
Manufacturer Street | BAYERWALDSTRASSE 15 |
Manufacturer City | MUNICH, 81737 |
Manufacturer Country | GM |
Manufacturer Postal Code | 81737 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | EDDY IRRIGATION TIP |
Generic Name | SYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING |
Product Code | EIC |
Date Received | 2019-12-31 |
Returned To Mfg | 2019-12-16 |
Model Number | NA |
Catalog Number | V041441000000 |
Lot Number | 301356 |
Operator | HEALTH PROFESSIONAL |
Device Availability | R |
Device Age | DA |
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 | 2019-12-31 |