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

Model Number	153905-002
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Code	Concussion (2192)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At the time of this reporting, the unit has not been made available, nor has any additional information been provided regarding the incident.Midmark is continuing to do its due diligence reaching out to the customer to get any additional information about the incident as well as trying to get the unit back.
Event or Problem Description
Midmark received a complaint of an adverse event in which a lighthead post of a ceiling mounted led dental light was reported to have come loose causing the post, and presumably also the light, to fall onto a dental hygienist resulting in a head injury reported to be a concussion.Due to previous reporting of this or similar light-falling events, midmark complied to report this instance.

• Brand Name: MIDMARK DENTAL LIGHT-LED, CEILING MOUNT
• 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 baker ; 60 vista drive; versailles, OH 45380 ; 3915267990
• MDR Report Key: 13059680
• Report Number: 1523530-2021-00006
• Device Sequence Number: 3912674
• Product Code: EAZ
• UDI-Device Identifier: 00841709107405
• UDI-Public: 00841709107405
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/20/2021

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: 153905-002
• Device Catalogue Number: 153905-002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2021
• Initial Report FDA Received Date: 12/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2021
• 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