MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-25 for LIGHT FANTASTIC II TRACK MOUNTED DENTAL LIGHT HBT LFTII manufactured by Pelton & Crane.
[81245357]
Upon evaluation by the distributor, it was determined the roll pins and set screws were not installed by the distributor during installation. The roll pins and set screws prevents the light from unscrewing from the trolley after installation. The distributor service technician ordered the roll pins and set screws and properly installed them on the dental light. The dental light was manufactured in may 1979 and is over 38 years old and past the expected life of the device.
Patient Sequence No: 1, Text Type: N, H10
[81245358]
It was reported that a pelton & crane dental light fell from the track assembly and struck the patient on the head causing a small laceration above the patients eye. General first aid was provided only. There were no serious injuries reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1017522-2017-00037 |
| MDR Report Key | 6742387 |
| Date Received | 2017-07-25 |
| Date of Report | 2017-06-28 |
| Date of Event | 2017-06-28 |
| Date Mfgr Received | 2017-06-28 |
| Device Manufacturer Date | 1979-05-11 |
| Date Added to Maude | 2017-07-25 |
| 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 | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| 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 MOUNTED DENTAL LIGHT |
| Generic Name | DENTAL LIGHT |
| Product Code | EAZ |
| Date Received | 2017-07-25 |
| Model Number | HBT |
| Catalog Number | LFTII |
| Operator | DENTAL HYGIENIST |
| 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 | 2017-07-25 |