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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ECO-MED PHARMACEUTICALS, INC. RED MEDIUM VISCOSITY ULTRASOUND GEL TRANSDUCER, ULTRASONIC, DIAGNOSTIC

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ECO-MED PHARMACEUTICALS, INC. RED MEDIUM VISCOSITY ULTRASOUND GEL TRANSDUCER, ULTRASONIC, DIAGNOSTIC Back to Search Results
Lot Number B045
Device Problem Patient Device Interaction Problem (4001)
Patient Problems Taste Disorder (4422); Cough (4457)
Event Date 06/07/2021
Event Type  Injury  
Event Description
I have been experiencing an unexplained difference in tasting and excreting chemical smells (burnt rubber). I have experienced issues with coughing as well but not severe and unrelated to covid. One of the areas with the strongest odor comes from the vaginal area. I noticed it was most potent after i sweat down there. I went to my ob/gyn and had an exam done and he was not able to detect anything. The symptoms occurred approximately a week after the first use. I stopped using it after noticing the changes. (b)(4). Fda safety report id # (b)(4).
 
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Brand NameRED MEDIUM VISCOSITY ULTRASOUND GEL
Type of DeviceTRANSDUCER, ULTRASONIC, DIAGNOSTIC
Manufacturer (Section D)
ECO-MED PHARMACEUTICALS, INC.
MDR Report Key12354106
MDR Text Key268053826
Report NumberMW5103411
Device Sequence Number1
Product Code ITX
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Type of Report Initial
Report Date 08/18/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
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

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