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U.S. Department of Health and Human Services

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

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ECO-MED PHARMACEUTICALS, INC. RED MEDICAL SUPPLIES ULTRASOUND GEL TRANSDUCER, ULTRASONIC, DIAGNOSTIC Back to Search Results
Lot Number B054
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Fever (1858); Unspecified Infection (1930)
Event Date 07/20/2021
Event Type  Injury  
Event Description
I had fever for over two weeks after i started using this gel with an ultrasound machine for a tummy tuck i had recently. I got an infection in my belly button and it has not heal and need to get a new surgery to fix; i was told by my doctor that was damaged. Red medical supplies ltd.
 
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Brand NameRED MEDICAL SUPPLIES ULTRASOUND GEL
Type of DeviceTRANSDUCER, ULTRASONIC, DIAGNOSTIC
Manufacturer (Section D)
ECO-MED PHARMACEUTICALS, INC.
MDR Report Key12474845
MDR Text Key271675486
Report NumberMW5103923
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 09/11/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot NumberB054
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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