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 2017-08-16 for TRANSLUX WAVE 66055012 manufactured by Kulzer, Gmbh.
[83213618]
(b)(4). Although we have not established that the device malfunctioned, 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 product problem could not yet be determined.
Patient Sequence No: 1, Text Type: N, H10
[83213619]
This occurred in (b)(6). Initial complaint was that translux wave curing light did not function. Upon examination, it became evident that the protective cover on the battery had been unwrapped by the end user.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005665377-2017-00002 |
| MDR Report Key | 6797994 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-08-16 |
| Date of Report | 2017-07-17 |
| Date Facility Aware | 2017-07-17 |
| Report Date | 2017-08-16 |
| Date Reported to FDA | 2017-08-16 |
| Date Reported to Mfgr | 2017-08-09 |
| Date Mfgr Received | 2017-07-17 |
| Device Manufacturer Date | 2016-12-15 |
| Date Added to Maude | 2017-08-16 |
| 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 G1 | KULZER, GMBH |
| Manufacturer Street | GRUNER WEG 11 |
| Manufacturer City | HANAU, GM 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 | 2017-08-16 |
| Returned To Mfg | 2017-08-09 |
| Model Number | 66055012 |
| Catalog Number | 66055012 |
| Operator | DENTIST |
| Device Availability | R |
| Device Age | 7 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KULZER, GMBH |
| Manufacturer Address | GRUNER WEG 11 HANAU, GM D-63450 GM D-63450 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-08-16 |