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

Device Problems Nonstandard Device (1420); Microbial Contamination of Device (2303)

Patient Problem Bacterial Infection (1735)

Event Date 08/17/2021

Event Type  Injury  

Event Description

Medichoice ultrasound gel bottle found at bedside of infant with positive sputum culture.Both grew burkholderia stabilis.Medichoice ultrasound gel was recalled for b.Stabilis contamination.Gel was found at the bedside of an infant whose sputum grew b.Stabilis.The organisms form the bottle and the infant were matched microbiology lab specimens and pfge.

• Brand Name: MEDICHOICE US GEL BOTTLE
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): ECO-MED PHARMACEUTICALS, INC.
• MDR Report Key: 12648072
• MDR Text Key: 277120915
• Report Number: MW5104660
• Device Sequence Number: 1
• Product Code: ITX
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 10/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 1 MO
• Patient Weight: 2