MAUDE Adverse Event Report: RED MEDICAL SUPPLIES MEDIUM VISCOSITY ULTRASOUND GEL; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Lot Number B046

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burning Sensation (2146)

Event Date 07/31/2021

Event Type  Injury  

Event Description

Felt a burning sensation while using the product.Only used product twice because of this.The first time was mid (b)(6).The most recent was used on the evening of saturday, (b)(6) 2021.Cleaned skin and tools that had this product on them both each time.Switched to an oil based product on wednesday (b)(6) 2021 everything was fine.No side effect with the other product.

• Brand Name: RED MEDICAL SUPPLIES MEDIUM VISCOSITY ULTRASOUND GEL
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• MDR Report Key: 12301587
• MDR Text Key: 266058655
• Report Number: MW5103127
• 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: 08/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/05/2024
• Device Lot Number: B046
• 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): Other
• Patient Age: 36 YR