MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-14 for LIGHT FANTASTIC III WALL MOUNT LFIIIWL manufactured by Pelton & Crane.
[95078770]
Upon visual inspection by the local pelton & crane distributor, it was determined that the positioning screw was not properly adjusted to the key on the light arm which holds the arm together. The device was not returned to pelton & crane but rather it was serviced and placed back into use at the doctor's office and has been tested and is now functioning properly. The dental light is more than 11 years old and is past the life of the device.
Patient Sequence No: 1, Text Type: N, H10
[95078771]
A medical professional was positioning a lfiiiwl wall mount dental light away after use when the light arm broke and fell down towards the ground. The doctor pushed the light away with her hand and said her wrist hurt for one minute and then the pain went away. There were no injuries reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1017522-2017-00069 |
| MDR Report Key | 7118617 |
| Date Received | 2017-12-14 |
| Date of Report | 2017-12-01 |
| Date of Event | 2017-12-01 |
| Date Mfgr Received | 2017-12-01 |
| Device Manufacturer Date | 2006-09-19 |
| Date Added to Maude | 2017-12-14 |
| 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 III WALL MOUNT |
| Generic Name | DENTAL LIGHT |
| Product Code | EAZ |
| Date Received | 2017-12-14 |
| Model Number | LFIIIWL |
| Catalog Number | LFIIIWL |
| Operator | DENTIST |
| 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 | 2017-12-14 |