MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-06 for LIGHT FANTASTIC II HBT LFTII manufactured by Kavo Dental Technologies, Llc.
[137955566]
Pelton & crane is in the process of gathering more information from the complaint issued to the (b)(6) court of justice. Once obtained we will submit a follow-up report with the results of our evaluation.
Patient Sequence No: 1, Text Type: N, H10
[137955567]
Pelton & crane became aware of an incident regarding a pelton & crane lftii dental light through an action filed by the ontario superior court of justice alleging the light fell on them prior to a procedure causing the dentist physical and mental injuries.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1017522-2019-00004 |
| MDR Report Key | 8394602 |
| Date Received | 2019-03-06 |
| Date of Report | 2019-03-06 |
| Date Mfgr Received | 2019-02-04 |
| Device Manufacturer Date | 1989-12-01 |
| Date Added to Maude | 2019-03-06 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. SHARON MILES |
| Manufacturer Street | 11727 FRUEHAUF DRIVE |
| Manufacturer City | CHARLOTTE NC 28273 |
| Manufacturer Country | US |
| Manufacturer Postal | 28273 |
| Manufacturer Phone | 7049270678 |
| 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 II |
| Generic Name | DENTAL LIGHT |
| Product Code | EAZ |
| Date Received | 2019-03-06 |
| Model Number | HBT |
| Catalog Number | LFTII |
| 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 | 1. Other | 2019-03-06 |