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

Lot Number B045

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Taste Disorder (4422); Cough (4457)

Event Date 06/07/2021

Event Type  Injury  

Event Description

I have been experiencing an unexplained difference in tasting and excreting chemical smells (burnt rubber).I have experienced issues with coughing as well but not severe and unrelated to covid.One of the areas with the strongest odor comes from the vaginal area.I noticed it was most potent after i sweat down there.I went to my ob/gyn and had an exam done and he was not able to detect anything.The symptoms occurred approximately a week after the first use.I stopped using it after noticing the changes.(b)(4).Fda safety report id # (b)(4).

• Brand Name: RED MEDIUM VISCOSITY ULTRASOUND GEL
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): ECO-MED PHARMACEUTICALS, INC.
• MDR Report Key: 12354106
• MDR Text Key: 268053826
• Report Number: MW5103411
• 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: 08/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• 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 Age: 44 YR
• Patient Weight: 64