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

Lot Number B045

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Fever (1858); Chills (2191); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/30/2021

Event Type  Injury  

Event Description

I was applying the gel 3 times a day for approximately a week before i started to run a fever, chills, and needed to be admitted.I was in intensive care for 11 days until the bacteria was surgically removed from my abdomen and a wound vac was placed.I was sent home with two weeks of antibiotics.

• Brand Name: RED MEDIUM VISCOSITY ULTRASOUND GEL
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): ECO-MED PHARMACEUTICALS, INC.
• MDR Report Key: 12358896
• MDR Text Key: 268048223
• Report Number: MW5103422
• 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: 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: B045
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 29 YR
• Patient Weight: 83