MAUDE Adverse Event Report: NATIONAL BIOLOGICAL CORP HANDISOL II; LIGHT, ULTRAVOILET, DERMATOLOGICAL

Model Number UVB-150

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Swelling (2091); Partial thickness (Second Degree) Burn (2694)

Event Date 03/22/2019

Event Type  Injury  

Event Description

I had been getting phototherapy treatments in an office to treat eczema.I was referred to national biological to get a home phototherapy unit.After receiving the home unit, i was given instructions by the nurse treating me in the phototherapy office on how much time to treat with my home unit.Based off numbers in the owners handbook, she told me to treat 4 minutes with my palms down and up.After that i would increase 15 seconds per treatment.I followed these instructions and doing everything i had read in the handbook and from the nurse.After this treatment, which was the first time i used this home unit, i received second degree burns.I had no issues immediately following the treatments.About 4 hours after the treatment, the burn started to develop.Saturday march 23, in the morning my forearms were very red, swollen and painful.That afternoon, small blisters started to develop on my left forearm.Sunday march 24, the blisters got bigger and i went to an urgent care, i was treated for the burns and given silvadene.The blisters developed further until march 26, and then got much better.After speaking to my dermatologists office, i had a follow up appointment with them to see the burns.They advised me to speak with the phototherapy office as well.When i spoke with the phototherapy office, the nurse who gave me the instructions went over her math, and did not know how this happened.I don't want this to happen to anyone else.Fda safety report id #: (b)(4).

• Brand Name: HANDISOL II
• Type of Device: LIGHT, ULTRAVOILET, DERMATOLOGICAL
• Manufacturer (Section D): NATIONAL BIOLOGICAL CORP
• MDR Report Key: 8503893
• MDR Text Key: 141800414
• Report Number: MW5085776
• Device Sequence Number: 1
• Product Code: FTC
• 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
• Report Date: 04/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: UVB-150
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 28 YR
• Patient Weight: 82