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U.S. Department of Health and Human Services

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

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ECO-MED PHARMACEUTICALS, INC. MEDICHOICE ULTRASOUND GEL TRANSDUCER, ULTRASONIC, DIAGNOSTIC Back to Search Results
Device Problem Microbial Contamination of Device (2303)
Patient Problems Bacterial Infection (1735); Sepsis (2067)
Event Date 08/12/2021
Event Type  Injury  
Event Description
Patient became septic with burkholderia cepacia bacteremia after bladderscan performed with medichoice ultrasound gel contaminated with burkholderia cepacia. The gel was on recall from the company.
 
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Brand NameMEDICHOICE ULTRASOUND GEL
Type of DeviceTRANSDUCER, ULTRASONIC, DIAGNOSTIC
Manufacturer (Section D)
ECO-MED PHARMACEUTICALS, INC.
MDR Report Key12447019
MDR Text Key270996776
Report NumberMW5103806
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 09/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Device Returned to Manufacturer
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: 09/08/2021 Patient Sequence Number: 1
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