MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-11-09 for HELIOS HL3C manufactured by Kavo Dental Technologies, Llc.
[126648486]
Upon evaluation by the pelton & crane authorized distributor it was determined the light arm set screw was not properly installed by the distributor during installation. The set screws will prevent the light from unscrewing from the light arm after installation. The pelton & crane installation instructions clearly states to properly install and secure the set screws during installation of the dental light. The installation instructions also lists warnings to ensure the set screws are installed and properly secured. Pelton & crance shipped set screws to the authorized pelton & crane dealer for installation on the dental light.
Patient Sequence No: 1, Text Type: N, H10
[126648487]
A dental assistant was cleaning a pelton & crane helios dental light when the light came apart and fell down towards the floor hitting the dental assistant on the side of the head causing a bump. There were no serious injuries reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1017522-2018-00028 |
| MDR Report Key | 8054586 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-11-09 |
| Date of Report | 2018-11-09 |
| Date of Event | 2018-10-15 |
| Date Mfgr Received | 2018-10-16 |
| Device Manufacturer Date | 2013-11-26 |
| Date Added to Maude | 2018-11-09 |
| 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 | HELIOS |
| Generic Name | DENTAL LIGHT |
| Product Code | EAZ |
| Date Received | 2018-11-09 |
| Model Number | HL3C |
| Catalog Number | HL3C |
| 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 | 2018-11-09 |