MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2015-03-11 for HELIOS 3000 TRACK MOUNTED LIGHT HL3T manufactured by Pelton And Crane.
[17574622]
It was reported that a dental professional was positioning a pelton and crane helios dental light for use when the light assembly fell down from the track assembly onto the pt's stomach. The dentist gave the pt an ice pack for their stomach as a precaution. There were no injuries reported.
Patient Sequence No: 1, Text Type: D, B5
[17736349]
Upon evaluation by the local pelton and crane distributor it was determined the roll pins were not installed by the distributor during installation. The roll pins will prevent the light from unscrewing form the pole after installation. The pelton and crane installation instructions clearly states to properly install the roll pins during installation of the track light. The installation instructions also lists warnings to insure the roll pins are installed. Pelton and crane reviewed with the distributor the proper installation process of the roll pins.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1017522-2015-00003 |
| MDR Report Key | 4594609 |
| Report Source | 08 |
| Date Received | 2015-03-11 |
| Date of Report | 2015-02-12 |
| Date of Event | 2015-02-12 |
| Date Mfgr Received | 2015-02-12 |
| Device Manufacturer Date | 2010-06-01 |
| Date Added to Maude | 2015-04-14 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | FRANK RAY |
| Manufacturer Street | 11727 FRUEHAUF DR. |
| Manufacturer City | CHARLOTTE NC 28273 |
| Manufacturer Country | US |
| Manufacturer Postal | 28273 |
| Manufacturer Phone | 7045877227 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HELIOS 3000 TRACK MOUNTED LIGHT |
| Generic Name | DENTAL LIGHT |
| Product Code | EAZ |
| Date Received | 2015-03-11 |
| Model Number | HL3T |
| Catalog Number | HL3T |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PELTON AND CRANE |
| Manufacturer Address | 11727 FRUEHAUF DR. CHARLOTTE NC 28273 US 28273 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-03-11 |