MAUDE Adverse Event Report: ECO MED PHARMACEUTICAL, INC. ULTRASOUND GEL; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Lot Number B045

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Bacterial Infection (1735)

Event Date 07/01/2021

Event Type  Injury  

Event Description

My wife and i have been to hospital and doctors at least 3 times for serious staph type infections from using red ultrasound gel.What do we do had spent thousands on surgery and had it cut out and sown up.We can supply doctors visits info.(b)(4).

• Brand Name: ULTRASOUND GEL
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): ECO MED PHARMACEUTICAL, INC.
• MDR Report Key: 12475214
• MDR Text Key: 272474045
• Report Number: MW5103943
• 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: 09/13/2021

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 Expiration Date: 05/04/2024
• 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 Outcome(s): Hospitalization
• Patient Age: 37 YR