ZERONA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-08-12 for ZERONA manufactured by .

Event Text Entries

[18255318] "good morning, i'm a disable client of this american skin laser here in (b)(6). Last (b)(6) 2013, i consulted this office about my stubborn fat to my stomach, and i spoke to (b)(4), and she said that it is guaranteed for more two weeks procedures, and my belly fat will be removed, for (b)(4). The zerona procedures, then she pushed me to get their special offer of skin tightening, and hair removal for (b)(4). She really pushed me to get it so she is a good sales agent. She is the mgr of this office, finished my zerona procedures, and it caused redness to my stomach. I called (b)(4) several times, but she ignored my file, then finally i got hold of her and she put me on hold for 30 minutes, then just hung up and never called me. Being a mgr she does not have good ethics. She said she will just do it again the procedures, but then i'm having some redness to my stomach already. Last (b)(6) 2013, she told me that i will get a refund for the (b)(4) to my credit. After a few days, i called their billing dept, and there was no changes made, so i called her again but no reply. I left a message for her assistant mgr and it still was the same. I sent her an email and i told her that i will write a letter to the attorney general. On (b)(6), she sent me a message saying that her company won't do a refund, but they will offer another procedure. I told them i do not want it. I took the pictures of my stomach. I had a reply from the attorney general's office. "this company has complaints and treated their clients by not calling back, and never give the credit that they promise. " i had a three multiple stab wounds to my chest, due to my homicide assault incident. I'm disabled, and i've been abused by this company. I had the pictures, and ready to send it to this agency. I told (b)(4), that my dermatologist in (b)(4) should stop this kind of procedures, because i will get a treatment to my skin as well, and it is not good, if i will have too much exposure to the lights. I had a severe damage to my left chest and neck due to my three multiple stab wounds to my chest, due to a homicide assault and robbery. I thought that these zerona procedure is really working. Even i followed their procedures, drinking 8 bottles a day, exercise, but it never worked. I had the copies of the complaints of their clients from the ripoff reports. Allergies: my skin turned red, because of too much exposure to the light. Jennifer grant lied to me, she told me that she will refund the (b)(4) last (b)(6) 2013 and my credit to their company will be reduced, then i made a follow up call again to her. Her assistant mgr talked to me, and she said that she will give the message to her. I've decided to send her an email again so it's all documented. I was told to send my pleadings to the attorney general's office, here in (b)(4). It was a procedure that cost you (b)(4), your stomach will be exposed to the lights for about 5 weeks, but nothing happened and i had a skin allergy. I took pictures of it. Also, during my first visit with (b)(4), she said that "i will be given a herbal, it will make you go to the bathroom", and i did refuse it. Dates of use: (b)(6) 2013. Event reappeared after reintroduction: yes. "
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5031414
MDR Report Key3289289
Date Received2013-08-12
Date of Report2013-08-11
Date of Event2013-04-27
Date Added to Maude2013-08-19
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 Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameZERONA
Generic NameLAZER
Product CodeOLI
Date Received2013-08-12
Device AvailabilityN
Device Sequence No1
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Deathisabilit 2013-08-12

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