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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 Name
RED MEDICAL SUPPLIES ECO-MED MEDIUM VISCOSITY ULTRASOUND GEL
Type of Device
TRANSDUCER, 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 No Information
Device Expiration Date05/04/2024
Device Lot NumberB045
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other; Disability;
Patient Age42 YR
Patient Weight68
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