MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-01-17 for FLUOR PROTECTOR S 639520AN manufactured by Ivoclar Vivadent Ag.
[64991776]
A total of 2 complaints were received: (b)(4) (catalog #639520an, batch no. (b)(4)) and (b)(4) (catalog # 639521an, no batch #) from the same dentist. The two catalog numbers are both for fluor protector s. Catalog #639520an is for fluor protector s refill 1x7g and 639521an is for fluor protector s refill 3x7g. The first event on (b)(6) 2016 ((b)(4)) occured when the fluor protector s tube burst while dispensing. The dispensing tip become disconnected from the tube and the material splashed on the assistant's safety/eye glasses and t-shirt. During the second event on (b)(6) 2016 ((b)(4), catalog # 639521an) the material burst out of the tube and splashed into the assistants eyes and face.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612352-2017-00001 |
| MDR Report Key | 6257166 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-01-17 |
| Date of Report | 2017-01-13 |
| Date of Event | 2016-11-22 |
| Date Mfgr Received | 2016-11-23 |
| Date Added to Maude | 2017-01-17 |
| 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 | DENTAL ASSISTANT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. DONNA HARTNETT |
| Manufacturer Street | 175 PINEVIEW DR |
| Manufacturer City | AMHERST NY 14228 |
| Manufacturer Country | US |
| Manufacturer Postal | 14228 |
| Manufacturer Phone | 7166912260 |
| Manufacturer G1 | IVOCLAR VIVADENT AG |
| Manufacturer Street | BENDERERSTRASSE 2 |
| Manufacturer City | SCHAAN, 9494 |
| Manufacturer Country | LS |
| Manufacturer Postal Code | 9494 |
| Single Use | 3 |
| Remedial Action | MA |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLUOR PROTECTOR S |
| Generic Name | VARNISH, CAVITY |
| Product Code | LBH |
| Date Received | 2017-01-17 |
| Catalog Number | 639520AN |
| Lot Number | V23022 |
| Operator | DENTIST |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IVOCLAR VIVADENT AG |
| Manufacturer Address | BENDERERSTRASSE 2 SCHAAN, 9494 LS 9494 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-01-17 |