SPERTI VITAMIN D LAMP

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-05-20 for SPERTI VITAMIN D LAMP manufactured by Kbd.

Event Text Entries

[3458932] I wanted to share with you a letter i sent to the mfr of the sperti vitamin d lamp. I followed the directions given and still got bad burns that i have had since the beginning of (b)(6). From my experience, following the usage guidelines of no more than every other day still resulted in burns. Also, info is limited on the dangers and possible length of time it takes for uv light burns to heal and how much it affects your life. After almost 3 months, i still can't be out in the sun for very long even with sunscreen and upf clothing. So, i hope you consider this info so that others can use this product w/o putting themselves at risk. (b)(6). Hello, i wanted to share my experience with your vitamin d lamp, so that you could take a look at your usage guidelines. I am a skin type 2 with no prior skin problems or burning problems with tanning in the sun. I also used a tanning bed once for 5 mins with no problems. Two weeks prior to using your lamp, i sunbathed in (b)(6) in (b)(6) for 20 mins a day w/o sunscreen with no problems. I followed the directions of using it no more than every other day starting at 3 mins at 15 inches. I alternated my back and front torso. On the 2nd week, i went to 4 mins and did not noticed any redness or pain. For the first two weeks, i had no problems. I no longer had vitamin d deficiency symptoms. On the 3rd week, i went to 5 mins and burned my back. My lower back was burned and my upper back had painful 1st degree burns. So, on my next session, since i had no prior problems for 4 mins, i limited my front to 4 mins and sunburned it as well. Also, i ended up with a burn line across my stomach. Since i couldn't expose these areas and was hesitant after being burned, i started on my front legs at 3 mins. After two sessions at 3 mins, my legs lightly burned, so i had to stop altogether. After a month, i still have skin rashes that flare up on my upper back. My stomach area still has light redness and a darker burn line across it. For safety reasons, if people can purchase this lamp w/o a doctor's supervision, the guidelines should be modified to prevent what happened to me. Every other day may be too much. Three times a week may be better. Having people start at one min and using it for two weeks 3 times a week and then going up a min may be more safe. Also, recommending staying at 3 mins may be, best if people see improvement. Another recommendation may be to have guideline's on maximum times based upon skin type. Also, give approximate vitamin production for every min used to give people info on exposing themselves as little as possible to meet their goals. (b)(6). Three to five mins every other day. Diagnosis or reason for use: vitamin d deficiency.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5030303
MDR Report Key3135323
Date Received2013-05-20
Date of Report2013-05-20
Date of Event2013-03-01
Date Added to Maude2013-05-30
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 FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameSPERTI VITAMIN D LAMP
Generic NameSPERTI VITAMIN D LAMP
Product CodeFTC
Date Received2013-05-20
Returned To Mfg2013-05-01
Lot NumberNA
OperatorLAY USER/PATIENT
Device AvailabilityR
Device Sequence No1
Device Event Key0
ManufacturerKBD
Manufacturer AddressCRESCENT SPRINGS KY US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2013-05-20

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