MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2016-02-03 for TRANSLUX? WAVE 66055012 manufactured by Heraeus Kulzer Gmbh.
[37420704]
(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. Because the malfunction allegation could not be confirmed, the cause of the adverse reaction could not be determined. This is classified as a near incident in that the timely intervention of staff will prevent any serious damage or impairment to the receptionist's physical state. Device not yet returned.
Patient Sequence No: 1, Text Type: N, H10
[37420725]
This occurred in (b)(6). Complaint from dental practice: handpiece 'smoking'. Receptionist burnt her finger on the device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005665377-2016-00001 |
| MDR Report Key | 5408267 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2016-02-03 |
| Date of Report | 2016-01-12 |
| Date of Event | 2016-01-12 |
| Date Facility Aware | 2016-01-12 |
| Date Mfgr Received | 2016-01-12 |
| Date Added to Maude | 2016-02-03 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. RITA ROGERS |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRANSLUX? WAVE |
| Generic Name | ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION |
| Product Code | EBZ |
| Date Received | 2016-02-03 |
| Catalog Number | 66055012 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| Device Age | 2 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. Other | 2016-02-03 |