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

Model Number	153901-003
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Multiple attempts have been made and documented to obtain futher information of both the injury and the falling light.At the time of this report, no further information has been made available to us by the customer.Upon further information received, midmark corporation will comply with a follow up report as applicable.
Event or Problem Description
It was reported to midmark corporation that on or around (b)(6) 2025, a led dental light fell and hurt a student at a dental college.The student received a pinch from the light.No further details of the severity of the injury has been made at the time of this report.Due to previous reporting of like instances of led dental lights falling, midmark corporation complied to report this instance.
Additional Manufacturer Narrative
Upon the initial report of the described instance within initial report, 1523530-2025-00001 on behalf of midmark corporation, multiple attempts were made to contact the customer to obtain further information of both the injury and the product malfunction.In the last correspondence from the customer, it was stated that after a review conducted by customers office, it does not appear that any malfunction of the light occurred that led to the student injury.No further action to be taken in this instance.
Event or Problem Description
It was reported to midmark corporation that on or around (b)(6) 2025, a led dental light fell and hurt a student at a dental college.The student received a pinch from the light.No further details of the severity of the injury has been made at the time of the initial report.Due to previous reporting of like instances of led dental lights falling, midmark corporation complied to report this instance.

• 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: sherrinda brumbaugh ; 60 vista drive; versailles, OH 45380
• MDR Report Key: 21389193
• Report Number: 1523530-2025-00001
• Device Sequence Number: 8292422
• Product Code: EAZ
• UDI-Device Identifier: 00841709107344
• UDI-Public: 00841709107344
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Model Number: 153901-003
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2025
• Supplement Date Received by Manufacturer: 01/22/2025
• Initial Report FDA Received Date: 02/14/2025
• Supplement Report FDA Received Date: 04/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/14/2020
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown