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

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).

• Brand Name: AQUASONIC 100
• Type of Device: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• Manufacturer (Section D): PARKER LABORATORIES, INC.
• MDR Report Key: 10307555
• MDR Text Key: 200191915
• Report Number: MW5095649
• Device Sequence Number: 1
• Product Code: IYO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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

• Date FDA Received: 07/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Weight: 59