ZERONA ERCHONIA LASER SCANNER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-03-21 for ZERONA ERCHONIA LASER SCANNER manufactured by Erchonia.

Event Text Entries

[3327422] Received 6 zerona treatments starting (b)(6) 2013 over period of 2 weeks. Initially no effects were experienced, however, mid-way approx (b)(6) 2013 started to experience itchy rash, low grade indigestion, belching. This which initially considered to be attributed to nutritional supplements as below-started (b)(6) 2013 taken concomittantly during zerona treatment. Mason natural 500 mg extended release niacin: 1 tablet per day, wegmans omega=3 triple strength : 1 capsule per day, wegmans herbal ginko biloba : 1 tablet twice per day, solgar l-carnitine 1000mg 1 tablet twice per day. The 6 zerona sessions were completed on (b)(6) 2013. Itchy rash and indigestion continued. (b)(6) 2013 experienced a confirmed uti; started 3 day course of cipro 500 starting (b)(6) 2013. Symptoms of uti disappeared by (b)(6) 2013. Itchy rash and indigestion continued. Started to use antacids prn for indigestion. Stopped taking nutritional supplements approx (b)(6) 2013. Demonstration of zerona efficacy was weak/questionable; however, the itchy rash and indigestion had persisted and both intensified despite stopping nutritional supplements. On (b)(6) 2013 started 7-day course of prednisone. During prednisone treatment, the itchiness of the rash was perhaps not as bothersome but the rash persisted as did the indigestion which in fact got worse. Pain, general discomfort, difficulty swallowing, belching, loss of appetite. Started taking zantac 75 prn to provide relief (b)(6) 2013. During prednisone course noticed that the rash 'came and went' and presented after showering/moisturising. It was also unusual that prednisone had little effect unlike previous instances of hives which would resolve very rapidly. After completion of prednisone course, the rash and worsening indigestion continued. Zantac dosing was now twice daily. Allergist appointment (b)(6) 2013 confirmed rash as 'dermatographia' and referred for blood tests. All were normal with exception of vitamin d deficiency. Allergist also recommended zyrtec at nighttime in addition to daily allegra already using. Started 2-week course of prevacid in addition to zantac twice a day on (b)(6) 2013. No adequate relief of indigestion/pain/difficulty swallowing/fatigue which by this time was interfering with work. The symptoms of reflux did not appear to be linked/related to meals or food intake and were now chronic during waking hours. (b)(6) 2013 experienced chills and fatigue. Later on in evening experienced fever and diarrhea which was large in volume, watery and difficult to control. The diarrhea and fatigue persisted for 2. 5 days. Took single dose of immodium on (b)(6) 2013. Started 3-day course of cipro 500 mg and probiotics (b)(6) 2013. And start attempt to avoid gluten and lactose in diet. Ceased taking prevacid and zantac 75. Diarrhea and fatigue returned (b)(6) 2013 but was marginally less severe. Lasted 1. 5 days. As of today continued to experience bothersome symptoms namely dermatographia, indigestion, belching, fatigue. Continued to take allegra morning and zyrtec night and zantac on occasion as necessary. Continued dietary gluten/dairy restrictions appear to help partly. Believe the 'histamine' effects and symptoms experienced are possibly related to zerona treatment and/or recommended nutritional supplements as part of zerona treatment.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5029485
MDR Report Key3022813
Date Received2013-03-21
Date of Report2013-03-21
Date of Event2013-01-11
Date Added to Maude2013-03-28
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 ERCHONIA LASER SCANNER
Generic NameZERONA
Product CodeOLI
Date Received2013-03-21
Lot NumberUNK
OperatorOTHER
Device AvailabilityN
Device Sequence No1
Device Event Key0
ManufacturerERCHONIA


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2013-03-21

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