MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-06-04 for LIGHT FANTASTIC + H3 LF+ manufactured by Kavo Dental Technologies, Llc.
[110028838]
The dental light is over 43 years old and past the life of the device. The dentist is disposing of the light and buying a new one.
Patient Sequence No: 1, Text Type: N, H10
[110028839]
A dentist was moving a pelton & crane dental light away after use when the light arm assembly broke and fell down towards the ground hitting the patient on the shin causing a laceration. The dentist said the patient required stitches as a result of the incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1017522-2018-00017 |
| MDR Report Key | 7567287 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-06-04 |
| Date of Report | 2018-06-04 |
| Date of Event | 2018-04-20 |
| Date Mfgr Received | 2018-05-07 |
| Device Manufacturer Date | 1975-06-01 |
| Date Added to Maude | 2018-06-04 |
| 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 | 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 + |
| Generic Name | DENTAL LIGHT |
| Product Code | EAZ |
| Date Received | 2018-06-04 |
| Model Number | H3 |
| Catalog Number | LF+ |
| Operator | DENTIST |
| 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. Required No Informationntervention | 2018-06-04 |