AQUASONIC 100 ULTRASOUND GEL

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-05-30 for AQUASONIC 100 ULTRASOUND GEL manufactured by .

Event Text Entries

[1194819] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5011264
MDR Report Key1397224
Date Received2009-05-30
Date of Report2009-05-30
Date of Event2005-01-01
Date Added to Maude2009-06-08
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 Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameAQUASONIC 100 ULTRASOUND GEL
Generic NameULTRASOUND GEL
Product CodeMJS
Date Received2009-05-30
Lot NumberUNKNOWN
Device AvailabilityY
Device Sequence No1
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
101. Life Threatening 2009-05-30

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