MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-06-08 for LIGHT FANTASTIC III TRACK MOUNT DENTAL LIGHT HBT-3 LFTIII manufactured by Pelton & Crane.
[15588976]
A dentist was positioning a pelton & crane dental light for use when the light arm assembly allegedly broke causing the light to fall down towards the ground. The light allegedly grazed the doctors forehead causing a minor scratch. There were no serious injuries reported.
Patient Sequence No: 1, Text Type: D, B5
[15716192]
Pelton & crane asked the dentist to return the components in question to pelton & crane for evaluation as a result of the alleged complaint. However, the dr refuses to cooperate and said they will not return the parts to pelton & crane.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1017522-2015-00011 |
| MDR Report Key | 4827008 |
| Report Source | 05,06 |
| Date Received | 2015-06-08 |
| Date of Report | 2015-05-15 |
| Date of Event | 2015-05-04 |
| Date Mfgr Received | 2015-05-15 |
| Device Manufacturer Date | 2007-09-01 |
| Date Added to Maude | 2015-06-24 |
| 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 | 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 | LIGHT FANTASTIC III TRACK MOUNT DENTAL LIGHT |
| Generic Name | DENTAL OPERATING LIGHT |
| Product Code | EAZ |
| Date Received | 2015-06-08 |
| Model Number | HBT-3 |
| Catalog Number | LFTIII |
| 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 & CRANE |
| Manufacturer Address | 11727 FRUEHAUF DR. CHARLOTTE NC 28273 US 28273 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-06-08 |