ZERONA LASER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-12-29 for ZERONA LASER manufactured by .

Event Text Entries

[1723172] In (b)(6), i went into dr (b)(6) office with a friend. He talked with me about a new laser, it's called the zerona. I trusted that it would be used correctly and help me achieve my goal. I was told the procedure had to be given every other day. On which i did show up for my appointments. I was asked to take curva, i'm not sure what was in it. The doctor didn't explain why i had to take it or what it was. I did take it. He also advised me to stay away from alcohol and coffee, which i did. I was told to drink 8 8oz glasses of water everyday, which i did. I had to eat right, which i do anyway. I have belonged to a gym for the past 7 years and work hard at keeping myself healthy. So i arrived on (b)(6), 2010 for my first treatment and had 5 others as he requested. However, on the fourth day, i asked why the fat tissues were not being flushed out of my system as he promised. I did have stomach problems from then on. I had to go to the bathroom more than usual. But i continued, upon receiving my 6th treatment, traveling quite a distance and dealing with stomach issues, there had been no progress, as the doctor had promised. I was upset and expressed that to the doctor. He was willing to give me 1 extra treatment and then pay for more, claiming i would then see the results. I refused. He had told me that the zerona was fda approved. Then why didn't it work? Why did i have stomach issues? I wasn't going to expose myself to anymore of his treatments. I think maybe he didn't use it properly and that is what caused the issues. I have since noticed he changed the name of his web site and got a new laser called lapexbcs laser. This lies directly on your stomach. If the zerona was the latest in technology why was a new laser brought in? I asked for a refund but he refused, he said because he tried to make me happy by giving me free treatment and more treatments. Why in the world would i want 1 more treatment if the first 6 didn't work and then pay him more money and have them not work either. He thought he was doing me a favor. No thanks, i'll keep my money and have my stomach go back to normal. Dates of use: (b)(6) 2010.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5018766
MDR Report Key1950628
Date Received2010-12-29
Date of Report2010-12-29
Date of Event2010-09-07
Date Added to Maude2011-01-12
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
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 NameZERONA LASER
Generic Name635 NM WAVELENGTH
Product CodeOLI
Date Received2010-12-29
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Sequence No1
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2010-12-29

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.