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 Problem Concussion (2192)

Event Type  Injury  

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 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
• 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 ; 3915267990
• MDR Report Key: 13059680
• MDR Text Key: 282613127
• Report Number: 1523530-2021-00006
• 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
• Type of Report: Initial
• Report Date: 12/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• 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: 12/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2021
• 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