HANDISOL II UVB-150

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-10 for HANDISOL II UVB-150 manufactured by National Biological Corp.

Event Text Entries

[141800414] 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).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5085776
MDR Report Key8503893
Date Received2019-04-10
Date of Report2019-04-08
Date of Event2019-03-22
Date Added to Maude2019-04-11
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameHANDISOL II
Generic NameLIGHT, ULTRAVOILET, DERMATOLOGICAL
Product CodeFTC
Date Received2019-04-10
Model NumberUVB-150
OperatorLAY USER/PATIENT
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerNATIONAL BIOLOGICAL CORP


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-04-10

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