MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-14 for LIGHT FANTASTIC II TRACK LIGHT HBT LFTII manufactured by Pelton & Crane.
[40650260]
The distributor replaced the spring assembly but accidentally disposed of the replaced component instead of returning it to pelton & crane for evaluation. The dental light is over 15 years old and is pasted the life of the device.
Patient Sequence No: 1, Text Type: N, H10
[40650261]
A dental professional was using a pelton & crane dental light when the counter balance arm assembly broke and dropped down towards the floor resulting in the light head contacting the back of the patients head. There were no injuries reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1017522-2016-00005 |
| MDR Report Key | 5497317 |
| Date Received | 2016-03-14 |
| Date of Report | 2016-02-15 |
| Date of Event | 2016-02-15 |
| Date Mfgr Received | 2016-02-15 |
| Device Manufacturer Date | 2001-11-28 |
| Date Added to Maude | 2016-03-14 |
| 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 |
| 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 | PELTON & CRANE |
| 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 | 0 |
| Brand Name | LIGHT FANTASTIC II TRACK LIGHT |
| Generic Name | DENTAL LIGHT |
| Product Code | EAZ |
| Date Received | 2016-03-14 |
| Model Number | HBT |
| Catalog Number | LFTII |
| Operator | DENTIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2016-03-14 |