MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-15 for TRANSLUX 2WAVE 66055013 manufactured by Kulzer Gmbh - Hq.
[175057263]
The dentist wanted to insert the battery into the device for the first start up. She has removed the protective foil around the battery pack before inserting the rechargeable battery. Very probably, a shortage of the battery occurred during insertion and the shortage wire got very hot. By the scare, the device fell to the ground and separated into pieces. The dentist suffered a very small, 3rd degree burn on her left hand middle finger. She went to see a doctor and had to close the dental surgery for that afternoon. This incident is reported out of an abundance of caution according to 21 cfr 803 as the fda might define this as a serious injury. This is assumed to the fact that the dentist reports seeking secondary medical care for his slight burn and there is a likely hood of reoccurrence if the user defoils/ unpacks the protective foil around the lithium ion rechargeable battery pack.
Patient Sequence No: 1, Text Type: N, H10
[175057264]
Very small 3rd degree burn on dentist's finger at trial of initial start-up of the device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005665377-2020-00001 |
| MDR Report Key | 9591322 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-01-15 |
| Date of Report | 2020-01-15 |
| Date of Event | 2019-12-10 |
| Date Added to Maude | 2020-01-15 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. ALBERT ERDRICH |
| Manufacturer Street | LEIPZIGER STRASSE 2 |
| Manufacturer City | HANAU, 63450 |
| Manufacturer Country | GM |
| Manufacturer Postal | 63450 |
| Manufacturer G1 | KULZER GMBH - HQ |
| Manufacturer Street | LEIPZIGER STRASSE 2 |
| Manufacturer City | HANAU, 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 |
| Generic Name | ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION, |
| Product Code | EBZ |
| Date Received | 2020-01-15 |
| Returned To Mfg | 2019-12-16 |
| Model Number | 2WAVE |
| Catalog Number | 66055013 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KULZER GMBH - HQ |
| Manufacturer Address | LEIPZIGER STRASSE 2 HANAU, 63450 GM 63450 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-15 |