MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-08 for TRANSLUX 2WAVE 66055013 manufactured by Kulzer Gmbh.
[174193171]
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. Out of an abundance of caution this incident is reportable according to 21 cfr 803. The fda defines this as a serious injury. As the dentist reports seeking secondary care and the likely hood of the reoccurrence if the foil/packaging around the battery is removed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[174193172]
Small 3rd degree burn on dentist's finger.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1821514-2020-00001 |
| MDR Report Key | 9565816 |
| Date Received | 2020-01-08 |
| Date of Report | 2020-01-06 |
| Date of Event | 2019-12-10 |
| Date Facility Aware | 2019-12-10 |
| Report Date | 2020-01-07 |
| Date Reported to Mfgr | 2020-01-07 |
| Date Added to Maude | 2020-01-08 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRANSLUX 2WAVE |
| Generic Name | ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION |
| Product Code | EBZ |
| Date Received | 2020-01-08 |
| Catalog Number | 66055013 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KULZER GMBH |
| Manufacturer Address | LEIPZIGER STRABE 2 HANAU, 63450 GM 63450 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-08 |