MAUDE Adverse Event Report: WARD PHOTONICS LLC ULTRASLIM RED LIGHT THERAPY; POWERED LASER SURGICAL INSTRUMENT

Device Problem Protective Measures Problem (3015)

Patient Problems Impaired Healing (2378); Blister (4537)

Event Date 01/24/2023

Event Type  Injury  

Event Description

On my 3rd visit for ultraslim red light therapy 2 blisters occurred on my left breast medial.The treatment was for my neck but the light was so positioned that it covered over my left breast which.I was wearing a two layer camisole and no additional covering was used.I told the owner about the blisters when she returned from being out of town.The next treatments were done using a mat that covered that area.Who knew this would become complicated.I didn't heal well as i've had many reconstructive surgeries on my chest as i am a breast cancer survivor.I have seen many doctors and i was told it would probably have to have a revision surgery on that breast.The owner (melissa) was really sorry about it and wanted to talk to mr ward the developer of the red light therapy.I just thought the fda should know about this hazard.

• Brand Name: ULTRASLIM RED LIGHT THERAPY
• Type of Device: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): WARD PHOTONICS LLC
• MDR Report Key: 16573839
• MDR Text Key: 311700151
• Report Number: MW5115842
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 107 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White