ZERONA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-07-29 for ZERONA manufactured by Erchonia Corporation.

Event Text Entries

[3675072] I feel the medical device called zerona manufactured by erchonia corporation should only be used by someone with a medical background, not by esthetician. I have consultation with two spas in (b)(6): i was given a consultation at both spas. I gave the esthetician all the information at the consultation and my medical history. If they have followed the procedure to provide me with the information according to the exclusion of zerona from the clinical trials and other research which was not advertised. I wouldn't be a candidate for the treatment. But, i wasn't given any information by the two spas except how many sessions i need in order to see the result. So, i went ahead and got the treatment. I don't think many people knows that there are two type of fat cells. They are subcutaneous fat and visceral fat. I have both. The medication caused me to have visceral fat which zerona does not reduced this type of fat. I wasn't given this information during the consultation at both spa. Around the week (b)(6) 2013, i have started to have pain at my upper thighs, lower part of my legs, my arms and my wrist everyday. The ibuprofen no longer work. I have to take naproxen everyday. I was using the naproxen only as needed for the back pain from the slip and fall accident. On (b)(6) 2013, it was raining all day. I started to have this excruciating pain started at my right side of my hip. It went around to my back, then to the left side of my hip. I felt pain then numbness at the lower part of my abdominal area. The next couple of days. I have pain around my pelvic area. I couldn't move. I went to see a local internal medicine doctor. The doctor's name is (b)(6). She refused to treat me. She wanted me to go back and see the pain management doctor. On (b)(6) 2013, i went to see my pain management doctor. The doctor is located at (b)(6). I got a pain killer call tramadol for the back problem. It worked for a day or two. It stop working. I was told by the physician assistant named (b)(6) to double the dosage. He wants me to see a rheumatologist for the other problems.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5031258
• MDR Report Key: 3261274
• Date Received: 2013-07-29
• Date of Report: 2013-07-29
• Date of Event: 2013-06-12
• Date Added to Maude: 2013-08-05
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ZERONA
• Generic Name: ZERONA NON-INVASIVE LOW LEVEL LASER LIPSUCTION
• Product Code: OLI
• Date Received: 2013-07-29
• Operator: OTHER
• Device Availability: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ERCHONIA CORPORATION
• Manufacturer Address: 2021 COMMERCE DR. MCKINNEY TX 75069 US 75069

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other; 2. Deathisabilit	2013-07-29