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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PARKER LABORATORIES, INC. AQUASONIC 100; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

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PARKER LABORATORIES, INC. AQUASONIC 100; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hypersensitivity/Allergic reaction (1907); Rash (2033)
Event Date 06/11/2020
Event Type  Injury  
Event Description
Developed hives and rash after echocardiogram using aquasonic 100 gel.Manufacturer (parker) will not disclose ingredients.I am highly allergic to multiple chemicals, with preservatives being the worst.I need to identify the offending ingredient to make sure i avoid this product (if it does include an offending substance) in the future but without the information regarding ingredients, i am unable to do so.I simply need to know the ingredients in aquasonic 100 gel as i had a severe reaction that last 3 weeks.Each time i am exposed to allergens the reaction is worse so knowing ingredients is knowing what products to avoid.Fda safety report id # (b)(4).
 
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Brand Name
AQUASONIC 100
Type of Device
SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
Manufacturer (Section D)
PARKER LABORATORIES, INC.
MDR Report Key10307555
MDR Text Key200191915
Report NumberMW5095649
Device Sequence Number1
Product Code IYO
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 07/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/21/2020
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age66 YR
Patient Weight59
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