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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ECO-MED PHARMACEUTICALS, INC. RED MEDICAL SUPPLIES, MEDIU VISCOSTY, ULTRASOUND GEL, BLUE COLOR TRANSDUCER, ULTRASONIC, DIAGNOSTIC

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ECO-MED PHARMACEUTICALS, INC. RED MEDICAL SUPPLIES, MEDIU VISCOSTY, ULTRASOUND GEL, BLUE COLOR TRANSDUCER, ULTRASONIC, DIAGNOSTIC Back to Search Results
Lot Number B030
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Bacterial Infection (1735); Sepsis (2067)
Event Date 06/10/2021
Event Type  Injury  
Event Description
After using the two bottles of blue color (ultrasound gel), i became hospitalized with a bacterial infection that spread to my blood. I was admitted for several days and was diagnosed with sepsis. I am still under the care of a physician. I am still being treated and monitored as a result of using this "producted. ".
 
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Brand NameRED MEDICAL SUPPLIES, MEDIU VISCOSTY, ULTRASOUND GEL, BLUE COLOR
Type of DeviceTRANSDUCER, ULTRASONIC, DIAGNOSTIC
Manufacturer (Section D)
ECO-MED PHARMACEUTICALS, INC.
MDR Report Key12318381
MDR Text Key266663234
Report NumberMW5103226
Device Sequence Number1
Product Code ITX
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 08/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot NumberB030
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
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: 08/12/2021 Patient Sequence Number: 1
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