MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-08-17 for ELEVANCE L/R LED DENTAL LIGHT 153901-002 manufactured by Midmark Corporation.
[82957408]
After review of pictures of the incident provided by the user facility the following explanation is the most likely cause of the light falling: the upper l/r light arm was out at a 90 degree angle from the dental chair toward a half-wall that was within the range of the light arm. When the dental chair was being lowered while the light was in this position, the light assembly would get caught on the half-wall which would cause the upper l/r arm to raise out of the joint. This would allow the light assembly and upper l/r arm to separate from lower l/r arm and tip toward the patient sitting in the dental chair. Additionally, the user facility stated they would not send the unit back for evaluation as they decided to assemble the dental light back together and resume using it. No servicing or replacements components were requested by the user facility.
Patient Sequence No: 1, Text Type: N, H10
[82957409]
During a root canal procedure, the l/r led dental light fell on the head of a patient, cutting the patient's head. The doctor present at that time stitched up the laceration.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1523530-2017-00003 |
| MDR Report Key | 6801679 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-08-17 |
| Date of Report | 2017-08-08 |
| Date of Event | 2017-07-08 |
| Date Mfgr Received | 2017-07-18 |
| Device Manufacturer Date | 2014-03-20 |
| Date Added to Maude | 2017-08-17 |
| 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. ADAM CLUTTER |
| Manufacturer Street | 60 VISTA DRIVE |
| Manufacturer City | VERSAILLES OH 45380 |
| Manufacturer Country | US |
| Manufacturer Postal | 45380 |
| Manufacturer Phone | 9375268474 |
| Manufacturer G1 | MIDMARK CORPORATION |
| Manufacturer Street | 60 VISTA DRIVE |
| Manufacturer City | VERSAILLES OH 45380 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 45380 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ELEVANCE L/R LED DENTAL LIGHT |
| Generic Name | DENTAL LED LIGHT |
| Product Code | EAZ |
| Date Received | 2017-08-17 |
| Model Number | 153901-002 |
| Catalog Number | 153901-002 |
| Operator | DENTIST |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MIDMARK CORPORATION |
| Manufacturer Address | 60 VISTA DRIVE VERSAILLES OH 45380 US 45380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-08-17 |