MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-04-13 for LIGHT FANTASTIC II HBT LFT II manufactured by Pelton & Crane.
[105372404]
The light is being disposed and is not being returned. The dental light is over 23 years old and past the life of the device.
Patient Sequence No: 1, Text Type: N, H10
[105372405]
It was reported that a pelton & crane dental light arm assembly broke causing the light arm to drop down and hit the patient. The dentist evaluated the patient and did not see any injuries however as a precaution the dentist sent the patient to the er for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1017522-2018-00012 |
| MDR Report Key | 7428263 |
| Report Source | USER FACILITY |
| Date Received | 2018-04-13 |
| Date of Report | 2018-04-03 |
| Date of Event | 2018-03-28 |
| Date Mfgr Received | 2018-04-03 |
| Device Manufacturer Date | 1994-09-01 |
| Date Added to Maude | 2018-04-13 |
| 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 | BIOMEDICAL ENGINEER |
| 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 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 | 2018-04-13 |
| Model Number | HBT |
| Catalog Number | LFT II |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PELTON & CRANE |
| Manufacturer Address | 11727 FRUEHAUF DRIVE CHARLOTTE NC 28273 US 28273 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-04-13 |