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

Lot Number B054

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Fever (1858); Unspecified Infection (1930)

Event Date 07/20/2021

Event Type  Injury  

Event Description

I had fever for over two weeks after i started using this gel with an ultrasound machine for a tummy tuck i had recently.I got an infection in my belly button and it has not heal and need to get a new surgery to fix; i was told by my doctor that was damaged.Red medical supplies ltd.

• Brand Name: RED MEDICAL SUPPLIES ULTRASOUND GEL
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): ECO-MED PHARMACEUTICALS, INC.
• MDR Report Key: 12474845
• MDR Text Key: 271675486
• Report Number: MW5103923
• 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: 09/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: B054
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Weight: 70