MAUDE Adverse Event Report: PHILIPS BURTON MEDICHOICE; MOBILE EXAM LIGHT

Model Number LGHT7400/LED

Device Problem Device Tipped Over (2589)

Patient Problems Laceration(s) (1946); No Code Available (3191)

Event Date 10/13/2014

Event Type  Injury  

Event Description

Patient has been seen in convenient care for stitches.Patient was lying on exam table and physician moved the portable (on wheels) exam light closer to complete treatment.Exam light easily became unbalanced and fell over on patient, striking them in the mouth and injuring the mouth (upper lip) and teeth.Patient had laceration and refused stitches.Patient subsequently went to dentist and may lose front teeth.

• Brand Name: MEDICHOICE
• Type of Device: MOBILE EXAM LIGHT
• Manufacturer (Section D): PHILIPS BURTON
• MDR Report Key: 4253561
• MDR Text Key: 5012192
• Report Number: MW5039073
• Device Sequence Number: 2
• Product Code: KZF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/07/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: LGHT7400/LED
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR