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U.S. Department of Health and Human Services

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

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ECO-MED PHARMACEUTICALS, INC. ECO-MED ULTRA SOUND GEL TRANSDUCER, ULTRASONIC, DIAGNOSTIC Back to Search Results
Device Problem Microbial Contamination of Device (2303)
Patient Problem Insufficient Information (4580)
Event Date 07/01/2021
Event Type  Injury  
Event Description
On august 4, 2020, the u. S. Food and drug administration (fda) issued a letter of voluntary recall to alert clinical laboratory staff and health care providers that (b)(6) eco-med pharmaceuticals, inc. Commenced a voluntary recall of certain lots of its eco-gel 200 ultrasound gel due to bacterial contamination. (b)(6) shortly followed with a health advisory to pull affected items. Eco-med has initiated this recall due to bacterial contamination in the affected lots of ultrasound gel with burkholderia cepacia complex (bcc). The source(s) of the bacterial contamination is currently unknown. Eco-med is conducting a comprehensive investigation to determine the root cause of this contamination and take all necessary corrective action. The effects of the bacteria, burkholderia stabilis, a member of the burkholderia cepacia complex (bcc), vary widely, ranging from no symptoms at all to serious infections. The use of the contaminated gel on this particular patient resulted in a false positive result from your ascites fluid. However, it was suspected to be a contaminate at the time of result due to the lack of robust growth on other microbiologic growth media. Upon review of your chart, your care team decisions and clinical treatments were not affected by the false results.
 
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Brand NameECO-MED ULTRA SOUND GEL
Type of DeviceTRANSDUCER, ULTRASONIC, DIAGNOSTIC
Manufacturer (Section D)
ECO-MED PHARMACEUTICALS, INC.
MDR Report Key12452833
MDR Text Key271322484
Report NumberMW5103833
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 09/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
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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