MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2014-09-16 for BLUEPHASE LIGHT PROBE 10MM BLACK (STYLE 636240 manufactured by Ivoclar Vivadent, Ag.
[5261988]
Probe broke in pt's mouth.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612352-2014-00016 |
| MDR Report Key | 4368645 |
| Report Source | 01 |
| Date Received | 2014-09-16 |
| Date of Report | 2014-09-15 |
| Date of Event | 2014-08-07 |
| Date Mfgr Received | 2014-09-09 |
| Date Added to Maude | 2015-01-15 |
| 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 | 0 |
| Manufacturer Contact | DR KIRK COURY |
| Manufacturer Street | 10 CARE CIRCLE STE A |
| Manufacturer City | ARMARILLO TX 791242139 |
| Manufacturer Country | US |
| Manufacturer Postal | 791242139 |
| Manufacturer Phone | 8063542424 |
| Manufacturer G1 | IVOCLAR VIVADENT, AG |
| Manufacturer Street | BENDERERSTRASSE 2 |
| Manufacturer City | SCHAAN FL-9494 |
| Manufacturer Country | LS |
| Manufacturer Postal Code | FL-9494 |
| Single Use | 0 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BLUEPHASE LIGHT PROBE 10MM BLACK (STYLE |
| Generic Name | ACTIVATORY, POLYMERIZATION |
| Product Code | EBZ |
| Date Received | 2014-09-16 |
| Catalog Number | 636240 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IVOCLAR VIVADENT, AG |
| Manufacturer Address | BENDERERSTRASSE 2 SCHAAN FL-9494 LS FL-9494 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-09-16 |