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

Model Number 153905-002

Device Problem Device Fell (4014)

Patient Problems Bruise/Contusion (1754); Neck Pain (2433)

Event Date 04/24/2023

Event Type  Injury  

Manufacturer Narrative

At the time of this reporting, the led ceiling light has been placed back into service.

Event Description

Midmark received a complaint of an adverse event in which a light head 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 an assistant and patient.The patient injury was documented to be bruising to chest and right breast.The assistant injury was documented to be right shoulder and pain in neck.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
• Type of Device: 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
• MDR Report Key: 16960514
• MDR Text Key: 315534095
• Report Number: 1523530-2023-00002
• Device Sequence Number: 1
• Product Code: EAZ
• UDI-Device Identifier: 00841709107405
• UDI-Public: 00841709107405
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 05/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 153905-002
• Device Catalogue Number: 153905-002
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2022
• 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