MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-09-05 for LIGHT FANTASTIC III LFIII manufactured by Kavo Dental Technologies, Llc.
[119501276]
The pelton & crane authorized dealer service technician informed pelton & crane that he replaced the spring assembly inside the lfiii dental light counter balance arm and then disposed of it. The dealer service technician informed pelton & crane he did not return the replaced spring assembly to pelton & crane because the light was no longer in warranty. As a result, pelton & crane is unable to evaluate the replaced spring assembly. The dental light is over 8 1/2 years old.
Patient Sequence No: 1, Text Type: N, H10
[119501277]
A dental professional was performing routine dental care to a patient when the dental light arm assembly broke causing the light to drop down towards the ground. The dental light hit the patient on the forehead causing a small bump which the doctor treated with an ice pack. No other medical attention was required.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1017522-2018-00025 |
| MDR Report Key | 7848097 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-09-05 |
| Date of Report | 2018-09-05 |
| Date of Event | 2018-08-07 |
| Date Mfgr Received | 2018-08-08 |
| Device Manufacturer Date | 2009-11-01 |
| Date Added to Maude | 2018-09-05 |
| 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 | MR. FRANK RAY |
| Manufacturer Street | 11727 FRUEHAUF DRIVE |
| Manufacturer City | CHARLOTTE NC 28273 |
| Manufacturer Country | US |
| Manufacturer Postal | 28273 |
| Manufacturer Phone | 7045877227 |
| Manufacturer G1 | KAVO DENTAL TECHNOLOGIES, LLC |
| Manufacturer Street | 11727 FRUEHAUF DRIVE |
| Manufacturer City | CHARLOTTE NC 28273 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 28273 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIGHT FANTASTIC III |
| Generic Name | DENTAL LIGHT |
| Product Code | EAZ |
| Date Received | 2018-09-05 |
| Model Number | LFIII |
| Catalog Number | LFIII |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KAVO DENTAL TECHNOLOGIES, LLC |
| Manufacturer Address | 11727 FRUEHAUF DRIVE CHARLOTTE NC 28273 US 28273 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-05 |