MAUDE Adverse Event Report: ECO-MED PHARM. BY RED MEDICAL SUPP / ECO-MED PHARMACEUTICALS, INC. ECOMED BLUE ULTRASOUND GEL FOR FETAL DOPPLER AND CAVITATION MACHINE; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Device Problems Fluid/Blood Leak (1250); Structural Problem (2506); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Burning Sensation (2146)

Event Date 04/25/2021

Event Type  Injury  

Event Description

The bottles i received from (b)(6) had leaked inside of the package.I thought this was just a shipping mishap so i attempted to use what was inside of the bottle with my doppler machine at home.Upon application of the gel, it immediately started burning.I wiped it off and washed with soap and water right away and the burning went away within 10 minutes or so and left me slightly red for about 20 minutes.I assumed i had some sort of an allergic reaction so i didn't use it again and contacted (b)(6) for a refund.(b)(6) instructed me to throw the product away and i did so on (b)(6) 2021.It was gel to use for a fetal doppler monitor.

• Brand Name: ECOMED BLUE ULTRASOUND GEL FOR FETAL DOPPLER AND CAVITATION MACHINE
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): ECO-MED PHARM. BY RED MEDICAL SUPP / ECO-MED PHARMACEUTICALS, INC.
• MDR Report Key: 12347753
• MDR Text Key: 267644012
• Report Number: MW5103359
• 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: 08/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2021
• Is this an Adverse Event Report?: Yes
• 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 Age: 35 YR
• Patient Weight: 81