FDA Adverse Event Injury Summary report: N

AQUASONIC 100 ULTRASOUND GEL

MDR report key: 1397224 · Received May 30, 2009

Report

Report Number
MW5011264
Event Type
Injury
Date Received
May 30, 2009
Date of Event
January 1, 2005
Report Date
May 30, 2009
Product Code
MJS
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
VA, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

DATE OF EVENTS NOT REMEMBERED. ON 2 SEPARATE OCCASIONS, I HAVE BEEN EXPOSED TO ULTRASOUND GEL AQUASONIC 100 WHICH DOES NOT STATE ALL INGREDIENTS ON PACKAGING. I SIMPLY STATES "BACTERIOSTATIC." WITH GREAT DIFFICULTY, THE HEALTH CARE PROVIDER WAS ABLE TO OBTAIN THE INFO FROM THE MANUFACTURER. IT CONTAINS A PRESERVATIVE, METHYLPARABEN, ONE OF THE GROUP OF PARABENS THAT I AM SEVERELY ALLERGIC TO. ON BOTH OCCASIONS, I HAD A SEVERE ANGIOEDEMA REACTION REQUIRING ORAL STEROIDS, INHALED STEROIDS, NEBULIZED ALBUTEROL, BOTH H1 AND H2 ANTIHISTAMINES FOR MANY WEEKS. I HAVE TO READ EVERY LABEL ON EVERYTHING I TOUCH, CONSUME, AND ALLOW IN MY PRESENCE. I CAN NOT TOUCH ANYONE WHO HAS SOMETHING CONTAINING A PARABEN ON THEM OR THEIR CLOTHING. EACH EXPOSURE IS WORSE THAN THE LAST, SO MY LIFE IS PRETTY MISERABLE. I HAVE A GOOD IDEA THAT THERE ARE NUMEROUS OTHER PEOPLE OUT THERE SUFFERING FROM SEVERE ASTHMA AND ALLERGIES WHO ARE ALLERGIC TO THIS VERY, VERY COMMON PRESERVATIVE THAT IS IN ALMOST EVERYTHING. THEY JUST ARE NOT AWARE OF IT. I FEEL THAT THEY DESERVE TO KNOWN ABOUT THE RISK OF THEIR BEING ALLERGIC TO THESE PARABENS. THANK YOU. OTHER SUSPECT MEDICAL DEVICES: BUPIVACAINE, TOPICALS, ETC. DIAGNOSIS OR REASON FOR USE: ULTRASOUND TO PAINFUL LUMP ON BACK. UTERINE ULTRASOUND. EVENT ABATED AFTER USE STOPPED: YES. EVENT REAPPEARED AFTER REINTRODUCTION: YES.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 AQUASONIC 100 ULTRASOUND GEL ULTRASOUND GEL MJS UNKNOWN

Patients

Seq Age Sex Outcome Treatment
1 49 YR Life Threatening