MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-04-01 for TRANSLUX WAVE 66055012 manufactured by Heraeus Kulzer Gmbh.
[5596780]
(b)(6) called me (b)(4) on friday evening to inquire about a new battery for a doctor in her territory. She said the doctor removed the white cover on the battery and shocked him self when he tried to re attach the wires. She sent me the attached email with the doctor's contact information. Dds removed the cover from his battery and the battery came apart. The light was sent on (b)(4) 2014 and is in warranty. He said he attempted to place the pieces back together and the wires arced and short circuited and a flash of light was seen and he said it felt like a white hot razor blade was pressed against his thumb causing a burn. I apologize for any problem he experienced and asked if he sought medical attention. He said he did not. I asked how his thumb is today and he said it is fine. He sent pictures of the battery and his thumb. I assured him this will be sent to our home office to ensure steps are taken so this does not happen again to another office.
Patient Sequence No: 1, Text Type: D, B5
[13037854]
(b)(4). Although we have not established that the device caused or contributed to the event, we're reporting it to be compliant with 21 cfr part 803 and out of an abundance of caution. Narrative: directions for use, page 7, states: do not disassemble or modify the battery! One li-ion mh12210 battery was received, in a box marked "defective battery. " battery had been disassembled into 6 parts and packed with the white cover which had originally protected all of the parts. The positive end showed a charred mark next to where the flat wire had been broken.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005665377-2015-00001 |
| MDR Report Key | 4648897 |
| Report Source | 05 |
| Date Received | 2015-04-01 |
| Date of Report | 2015-03-09 |
| Date of Event | 2015-03-06 |
| Date Facility Aware | 2015-03-09 |
| Date Mfgr Received | 2015-03-09 |
| Device Manufacturer Date | 2013-06-01 |
| Date Added to Maude | 2015-04-01 |
| 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 | 0 |
| Event Location | 0 |
| 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 GMBH |
| Manufacturer Street | GRUNER WEG 11 |
| Manufacturer City | HANAU, 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 | 2015-04-01 |
| Returned To Mfg | 2015-03-19 |
| Catalog Number | 66055012 |
| Operator | DENTIST |
| Device Availability | R |
| Device Age | 21 MO |
| 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 | 2015-04-01 |