MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-06 for TRANSLUX WAVE manufactured by Heraeus Kulzer Gmbh.
[69499464]
(b)(4). Although we have not established that the device caused or contributed to the event, we are reporting 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 malfunction has not been determined. This is classified as a near incident in that the timely intervention of the staff prevented any serious impairment to her hand. Device not yet evaluated.
Patient Sequence No: 1, Text Type: N, H10
[69499465]
This occurred in (b)(6). Patient complained that curing light was hot for anterior restorations. Tested by staff and left burn mark on hand.
Patient Sequence No: 1, Text Type: D, B5
[73357520]
(b)(4). Although we have not established that the device caused or contributed to the event, we are reporting 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 malfunction has not been determined. This is classified as a near incident in that the timely intervention of the staff prevented any serious impairment to her hand. On 3/21/2017 addendum/correction. Upon return of the translux power blue curing light in question, and thorough testing, the light is in excellent condition and no defect was detectable. This is a perception issue and would not be possible to cause any skin irritation.
Patient Sequence No: 1, Text Type: N, H10
[73357521]
This occurred in (b)(6). Patient complained that curing light was hot for anterior restorations. Tested by staff and left burn mark on hand. On 3/21/2017 addendum/correction. Upon return of the translux power blue curing light in question, and thorough testing, the light is in excellent condition and no defect was detectable. This is a perception issue and would not be possible to cause any skin irritation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005665377-2017-00001 |
| MDR Report Key | 6381112 |
| Date Received | 2017-03-06 |
| Date of Report | 2017-02-15 |
| Date of Event | 2017-02-15 |
| Date Facility Aware | 2017-02-15 |
| Date Mfgr Received | 2017-02-15 |
| Date Added to Maude | 2017-03-06 |
| 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 | 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, LLC |
| Manufacturer Street | 300 HERAEUS WAY |
| Manufacturer City | SOUTH BEND IN 466142517 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 466142517 |
| 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 | 2017-03-06 |
| Returned To Mfg | 2017-03-03 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-03-06 |