MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-05-17 for TRANSLUX? WAVE 66055012 manufactured by Kulzer,llc.
[109024829]
(b)(4). This malfunction is reportable according to 21 cfr 803. As this sort of malfunction may cause or contribute to a death or serious injury, if the malfunction were to reoccur. "malfunction" means the failure of a device to meet its performance specifications or otherwise perform as intended. This is a singular event. Practitioner complained of smell of burnt plastic. Neither patient, practitioner nor third party was injured, but we are reporting out of an abundance of caution. If this were to reoccur the heat generated may cause injury.
Patient Sequence No: 1, Text Type: N, H10
[109024830]
Curing light hand piece heated up, melted voltage meter on pcb.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005665377-2018-00001 |
| MDR Report Key | 7523112 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-05-17 |
| Date of Report | 2018-04-27 |
| Date Facility Aware | 2018-04-27 |
| Date Mfgr Received | 2018-04-27 |
| Device Manufacturer Date | 2017-11-01 |
| Date Added to Maude | 2018-05-17 |
| 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 | MRS. RITA ROGERS |
| Manufacturer Street | 4315 SOUTH LAFAYETTE BLVD. |
| Manufacturer City | SOUTH BEND 46614 |
| Manufacturer Country | US |
| Manufacturer Postal | 46614 |
| Manufacturer Phone | 5742995409 |
| Manufacturer G1 | KULZER,LLC |
| Manufacturer Street | LEIPZIGER STRABE 2 |
| Manufacturer City | HANAU, HESSEN 63450 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 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 | 2018-05-17 |
| Returned To Mfg | 2018-04-30 |
| Catalog Number | 66055012 |
| Operator | DENTIST |
| Device Availability | R |
| Device Age | 1 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KULZER,LLC |
| Manufacturer Address | LEIPZIGER STRABE 2 HANAU, HESSEN 63450 GM 63450 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-05-17 |