MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-08 for RESIN/ROOT CANAL FILLING manufactured by .
Report Number | MW5056112 |
MDR Report Key | 5075020 |
Date Received | 2015-09-08 |
Date of Report | 2015-09-08 |
Date Added to Maude | 2015-09-14 |
Event Key | 0 |
Report Source Code | Voluntary report |
Manufacturer Link | N |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 3 |
Reporter Occupation | PATIENT |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 0 |
Brand Name | RESIN/ROOT CANAL FILLING |
Generic Name | RESIN/ROOT CANAL FILLING |
Product Code | KIF |
Date Received | 2015-09-08 |
Device Availability | Y |
Device Eval'ed by Mfgr | * |
Device Sequence No | 1 |
Device Event Key | 0 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Other; 4. Deathisabilit | 2015-09-08 |