MAUDE Adverse Event Report: MIDMARK CORP. MIDMARK; LIGHT, OPERATING, DENTAL

Model Number 18600

Device Problem Component Falling (1105)

Patient Problem Burn(s) (1757)

Event Date 05/01/2014

Event Type  Injury  

Event Description

While positioning the light, the light fell off and the assistant caught the analog shade and received a burn on her hands.

Manufacturer Narrative

The serial number of the light was not available.The product literature states "caution, the bulb may be hot! allow the bulb to cool for at least 5 minutes before removing the light shield." also noted in the instructions are the use of two 'release levers' for installation and for maintenance to ensure that the light shield is properly fastened.The facility failed to do this which led to the operator being burned.

• Brand Name: MIDMARK
• Type of Device: LIGHT, OPERATING, DENTAL
• Manufacturer (Section D): MIDMARK CORP.; versailles OH
• Manufacturer Contact: craig rammel ; 60 vista dr.; versailles, OH 45380 ; 9375263662
• MDR Report Key: 3877795
• MDR Text Key: 4569342
• Report Number: 1523530-2014-00010
• Device Sequence Number: 1
• Product Code: EAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 05/31/2014

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: 18600
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/01/2014
• Initial Date FDA Received: 05/31/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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