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

0 Patients were 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

• Device Lot Number: B045
• Was Device Available for Evaluation?: Yes

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage