ZERONA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-10-29 for ZERONA manufactured by Erchonia.

Event Text Entries

[2295097] I had a series of zerona laser treatments over a period of 8 weeks in (b)(6) 2011. The treatments were very successful in that i lost several inches. During the weeks, i received treatments i experienced tingling in my abdomen, low grade fevers, fatigue and mild flu like symptoms. Other patients mentioned to me that they experienced flu like symptoms as well so i didn't think much of it. However, my symptoms did not completely resolve. On (b)(6) 2011, my gp sent me to the emergency room for acute abdomen symptoms, extreme abdominal distention, abdominal pain, and vomiting. No cause could be determined. Flulike symptoms, abdominal distention, abdominal tingling sensation, and fevers continued in episodes following the (b)(6) er visit. Symptoms became progressively worse and now involve lymphatic swelling in hips. I was referred to several specialists to rule out all potential causes. By (b)(6), i was on medical leave due to this illness. I became unable to stand or sit for more than 1 hour due to swelling. The only resolve is to lay flat for 2 or 3 days at a time. On (b)(6) 2011, i underwent open abdomen exploratory surgery, appendectomy and removal of right ovary. My bowel was run. No malignancy was found. I was hospitalized 7 days and required a blood transfusion. I also developed pulmonary vascular congestion. Fevers never resolved. Abdominal distention of approximately 8 to 10 inches returned 12 days following surgery. I have been evaluated by several specialist at (b)(6), as well as a liver specialist, gastroenterologist, oncologist, hematologist, infectious disease specialist, rheumatologist, endocrinologist, and my gp who is a d. O. I am currently being evaluated by an immunologist who urged me to contact the manufacturer of zerona to report this adverse event. I emailed the manufacturer and have not yet heard back. Given that other patients told me they experienced body ache and fevers with zerona treatments, i have concerns that this new device may pose a health risk to some individuals. I am not unhappy with the center who provided treatments. I had excellent cosmetic results. However, i am still very ill and unable to function. I spend most hours of the day laying flat to relieve the pressure caused by the lymphatic swelling and abdominal distention. Dates of use: (b)(6) 2011.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5022904
MDR Report Key2321291
Date Received2011-10-29
Date of Report2011-10-29
Date of Event2011-03-25
Date Added to Maude2011-11-04
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 NameZERONA
Generic NameZERONA
Product CodeOLI
Date Received2011-10-29
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Sequence No1
Device Event Key0
ManufacturerERCHONIA
Manufacturer AddressMCKINNEY TX US


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Other; 3. Required No Informationntervention; 4. Deathisabilit 2011-10-29

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