MAUDE Adverse Event Report: MIDMARK CORPORATION MIDMARK; LED DENTAL LIGHT,

Model Number	153905-002
Medical Device Problem Code	Misassembly by Users (3133)
Health Effect - Clinical Code	Bruise/Contusion (1754)
Date of Event	01/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Information received in the service request and pictures of the device in question verify the reported event is consistent with a previously identified issue with setup instructions not being followed.The issue has since been addressed.
Event or Problem Description
It was reported to midmark that a led light and post that connects to the ceiling became loose resulting in the assembly to fall.At the time of the incident the office personnel (assistant) was pulling the light towards her while cleaning it.There was no patient sitting in the chair at the time of the event.The office reported the assistant received light bruising, but did not seek addiitional medical attention.Midmark is reporting this incident due to previous reporting of similiar incidents.

• Brand Name: MIDMARK
• Common Device Name: LED DENTAL LIGHT,
• Manufacturer (Section D): MIDMARK CORPORATION; 60 vista drive; versailles OH 45380
• Manufacturer (Section G): MIDMARK CORPORATION; 60 vista drive; versailles OH 45380
• Manufacturer Contact: kort fledderjohann ; 60 vista drive; versailles, OH 45380
• MDR Report Key: 24224168
• Report Number: 1523530-2026-00001
• Device Sequence Number: 13107698
• Product Code: EAZ
• UDI-Device Identifier: 00841709107405
• UDI-Public: 00841709107405
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: 505
• Type of Report: Initial
• Report Date (Section B): 01/30/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 153905-002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/08/2026
• Initial Report FDA Received Date: 01/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/31/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown