MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2015-09-02 for LIGHT FANTASTIC II TRACK MOUNT LIGHT HBT LFTII manufactured by Pelton & Crane.
[24794579]
The complete device was not returned to pelton & crane as the pelton & crane distributor had already repaired the dental light by replacing the counterbalance spring assembly. However, during follow-up communication with the doctors office, the replaced counterbalance spring assembly was still in the dr. 's possession therefore pelton & crane had the part returned for evaluation. Pelton & crane received the counterbalance spring assembly august 19, 2015. Upon evaluation of the spring assembly, it was identified that the two pivot studs located on both sides of the friction block were broken off due to suspected excessive loading therefore the spring assembly could not counterbalance the light head assembly. The pelton & crane dental track light was manufactured twenty-six (26) years ago in august 1989 and is past the life of the device. Furthermore, dr. (b)(6) purchased the dental track light used in 2006 from another dentist.
Patient Sequence No: 1, Text Type: N, H10
[24794580]
A dental hygienist was performing routine dental treatment with a patient when a pelton & crane lftii dental light counter balance arm assembly failed causing the light arm to drop down towards the ground. The light arm dropped approximately one to two feet then struck the dental assistant on the right side of her head. The dental assistant went to the hospital due to feeling pain and was diagnosed with a fracture of the occipital bone and a contusion. The dental hygienist stayed in the hospital for two nights and was then released.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1017522-2015-00019 |
| MDR Report Key | 5048942 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2015-09-02 |
| Date of Report | 2015-08-05 |
| Date of Event | 2015-07-08 |
| Date Mfgr Received | 2015-08-05 |
| Device Manufacturer Date | 1989-08-31 |
| Date Added to Maude | 2015-09-02 |
| 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 | 3 |
| Brand Name | LIGHT FANTASTIC II TRACK MOUNT LIGHT |
| Generic Name | DENTAL LIGHT |
| Product Code | EAZ |
| Date Received | 2015-09-02 |
| Model Number | HBT |
| Catalog Number | LFTII |
| Operator | DENTAL HYGIENIST |
| 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 | 1. Hospitalization; 2. Required No Informationntervention | 2015-09-02 |