MAUDE Adverse Event Report: MIDMARK CORPORATION MIDMARK; DENTAL FLEX ARM ASSEMBLY

Model Number	029-4857-00
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	04/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Servicer was advised to contact midmark when onsite to complete repair of device.No further details obtained at time of this report.
Event or Problem Description
This report provides a detailed account of an incident involving the detachment of a dental light flex arm assembly.It has been reported that a dental assistant was adjusting the equipment when it detached from its ceiling mount, subsequently falling onto a patient below.The patient sustained minor cuts to the head as a result of this accident.Given the occurrence of similar incidents in the past, midmark corporation has adhered to regulatory requirements and reported this event accordingly.

• Brand Name: MIDMARK
• Common Device Name: DENTAL FLEX ARM ASSEMBLY
• 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: 19190021
• Report Number: 1523530-2024-00002
• Device Sequence Number: 7620253
• Product Code: EAZ
• UDI-Device Identifier: 00841709106897
• UDI-Public: 00841709106897
• 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): Y
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 04/26/2024

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: Health Professional
• Device Model Number: 029-4857-00
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2024
• Initial Report FDA Received Date: 04/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/17/2009
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown