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

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.

• Brand Name: MEDICHOICE ULTRASOUND GEL
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): ECO-MED PHARMACEUTICALS, INC.
• MDR Report Key: 12447019
• MDR Text Key: 270996776
• Report Number: MW5103806
• 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: 09/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 94 YR