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

Model Number 029-4857-00

Device Problem Device Fell (4014)

Patient Problem Laceration(s) (1946)

Event Date 04/09/2024

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 341120252
• Report Number: 1523530-2024-00002
• Device Sequence Number: 1
• Product Code: EAZ
• UDI-Device Identifier: 00841709106897
• UDI-Public: 00841709106897
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 029-4857-00
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/09/2024
• Initial Date FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/17/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other