MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2014-01-10 for TRANSLUX? POWER BLUE 66017507 manufactured by Heraeus Kulzer Gmbh.
[17928489]
This is the fifth of six reports involving 6 different devices and 4 patients. A dental office has a curing light that they said is not curing properly. They have had to remove and re do 6 fillings so far. On (b)(6) 2013 spoke with assistant. She said that they only had 4 patients involved. She said that they would try the lights and when they did not cure they would grab another light and try it. They did not reuse it once it failed to cure. She said that they tried to cure for 40 seconds but the composite was still soft. She said that the lights did not seem to have enough curing power to cure the composite.
Patient Sequence No: 1, Text Type: D, B5
[18155466]
(b)(4). Although we have not established that the device caused or contributed to the event, we're reporting it to be compliant with 21 cfr part 803 and out of an abundance of caution. Device has not been received for testing. Evaluation pending return of complaint unit.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005665377-2014-00005 |
| MDR Report Key | 3567335 |
| Report Source | 05,07 |
| Date Received | 2014-01-10 |
| Date of Report | 2013-12-11 |
| Date Facility Aware | 2013-12-11 |
| Date Mfgr Received | 2013-12-11 |
| Date Added to Maude | 2014-01-10 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. AUDI BOGUCKI |
| Manufacturer Street | 300 HERAEUS WAY |
| Manufacturer City | SOUTH BEND IN 46614 |
| Manufacturer Country | US |
| Manufacturer Postal | 46614 |
| Manufacturer Phone | 5742995409 |
| Manufacturer G1 | HERAEUS KULZER GMBH |
| Manufacturer Street | GRUNER WEG 11 |
| Manufacturer City | HANAU, D-63450 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D-63450 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRANSLUX? POWER BLUE |
| Generic Name | ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION |
| Product Code | EBZ |
| Date Received | 2014-01-10 |
| Catalog Number | 66017507 |
| Operator | DENTIST |
| Device Availability | N |
| Device Age | 22 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HERAEUS KULZER GMBH |
| Manufacturer Address | GRUNER WEG 11 HANAU, D-63450 GM D-63450 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-01-10 |