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

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.

• Brand Name: ECO-MED ULTRA SOUND GEL
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): ECO-MED PHARMACEUTICALS, INC.
• MDR Report Key: 12452833
• MDR Text Key: 271322484
• Report Number: MW5103833
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 09/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/09/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 75