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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ECO-MED PHARMACEUTICALS, INC. RED MEDICAL SUPPLIES ECO-MED MEDIUM VISCOSITY ULTRASOUND GEL TRANSDUCER, ULTRASONIC, DIAGNOSTIC
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ECO-MED PHARMACEUTICALS, INC. RED MEDICAL SUPPLIES ECO-MED MEDIUM VISCOSITY ULTRASOUND GEL TRANSDUCER, ULTRASONIC, DIAGNOSTIC Back to Search Results
Lot Number B045
Device Problem Patient Device Interaction Problem (4001)
Patient Problems Conjunctivitis (1784); Hemorrhage/Bleeding (1888); Blurred Vision (2137); Localized Skin Lesion (4542); Swelling/ Edema (4577)
Event Date 07/15/2021
Event Type  Injury  
Event Description
I recently bought the eco med blue gel inline at (b)(6) for microdermabrasion for my face. I noticed about two days afterward that my face was swelling and started to break out with lesions. It has gotten worse. I got the notice today in my email about this gel i ordered and the contamination. I can barely touch the lesions and they bleed a lot when pressed. They have spread to my arms and back of legs and buttocks, front of my thigh and face. My eyesight has been blurry lately and i've had pinkeye 3 times since using it. I have not been to the doctor yet. I have been trying to self treat at home. Can you recommend a doctor or group to go to?.
 
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Brand NameRED MEDICAL SUPPLIES ECO-MED MEDIUM VISCOSITY ULTRASOUND GEL
Type of DeviceTRANSDUCER, ULTRASONIC, DIAGNOSTIC
Manufacturer (Section D)
ECO-MED PHARMACEUTICALS, INC.
6155 tomken road unit 13
mississauga, ontario L4W 1 H3
CA L4W 1H3
MDR Report Key12294402
MDR Text Key265808682
Report NumberMW5103097
Device Sequence Number1
Product Code ITX
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Type of Report Initial
Report Date 08/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot NumberB045
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 08/06/2021 Patient Sequence Number: 1
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