MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-09-24 for BLUEPHASE LIGHT PROBE 10MM BLACK (STYLE) 636240 manufactured by Ivoclar Vivadent, Gmbh.
[5111103]
Probe broke in pts mouth.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000493628-2014-00001 |
| MDR Report Key | 4249718 |
| Report Source | 05 |
| Date Received | 2014-09-24 |
| Date of Report | 2014-09-15 |
| Date of Event | 2014-08-07 |
| Date Mfgr Received | 2014-08-12 |
| Date Added to Maude | 2014-11-17 |
| 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 | MS SANDRA CAKEBREAD |
| Manufacturer Street | BENDERERSTRASSE 2 |
| Manufacturer City | SCHAAN FL-9494 |
| Manufacturer Country | LS |
| Manufacturer Postal | FL-9494 |
| Manufacturer Phone | 2353535 |
| Manufacturer G1 | IVOCLAR VIVADENT, GMBH |
| Manufacturer Street | BREMSCHLSTRASSE 16 |
| Manufacturer City | BURS A-6706 |
| Manufacturer Country | AU |
| Manufacturer Postal Code | A-6706 |
| Single Use | 3 |
| 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 | 2014-09-24 |
| Catalog Number | 636240 |
| Operator | OTHER |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IVOCLAR VIVADENT, GMBH |
| Manufacturer Address | BREMSCHLSTRASSE 16 BURS A-6706 AU A-6706 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-09-24 |