MAUDE Adverse Event Report: ANODYNE LIGHT THERAPY ANODYNE LIGHT THERAPY

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Burn(s) (1757); Pain (1994); Swelling (2091)

Event Date 05/07/2015

Event Type  Injury  

Event Description

Went to (b)(6) ctr for anodyne light therapy treatment on (b)(6).Treatment was administered longer than protocol and skin condition was not checked every 10 minutes.Burns were noticed that evening with pain and extreme swelling.Went to er, (b)(6) emergency room in (b)(6) was treated for burns, pain, and swelling.

• Brand Name: ANODYNE LIGHT THERAPY
• Type of Device: ANODYNE LIGHT THERAPY
• Manufacturer (Section D): ANODYNE LIGHT THERAPY
• MDR Report Key: 4777300
• MDR Text Key: 5951165
• Report Number: MW5042730
• Device Sequence Number: 1
• Product Code: ILY
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Patient Sequence Number: 1
• Treatment: METFORMIN; LIPITOR; EXFORGE
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 51 YR
• Patient Weight: 73