MAUDE Adverse Event Report: ECO-MED PHARMACEUTICALS, INC. RED MEDICAL SUPPLIES, MEDIU VISCOSTY, ULTRASOUND GEL, BLUE COLOR; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Lot Number B030

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Bacterial Infection (1735); Sepsis (2067)

Event Date 06/10/2021

Event Type  Injury  

Event Description

After using the two bottles of blue color (ultrasound gel), i became hospitalized with a bacterial infection that spread to my blood.I was admitted for several days and was diagnosed with sepsis.I am still under the care of a physician.I am still being treated and monitored as a result of using this "producted.".

• Brand Name: RED MEDICAL SUPPLIES, MEDIU VISCOSTY, ULTRASOUND GEL, BLUE COLOR
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): ECO-MED PHARMACEUTICALS, INC.
• MDR Report Key: 12318381
• MDR Text Key: 266663234
• Report Number: MW5103226
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 03/30/2024
• Device Lot Number: B030
• 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
• Patient Age: 39 YR
• Patient Weight: 86