MAUDE Adverse Event Report: ECO-MED PHARMACEUTICALS, INC. ECO MED PHARMACEUTICAL ULTRA SOUND GEL; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Itching Sensation (1943); Pain (1994); Rash (2033)

Event Date 08/01/2021

Event Type  Injury  

Event Description

I'm a cosmetic laser technician.I received a recall notice about a gel i've been using for laser hair removal and a fat reduction machine.I have a rash all over my back that is itchy and hurts.I've also started getting a sharp pain in my right foot heel area.I do have the products still.However i'm not there right now so i can't upload the pictures but i do have them and can send at another time.Gel is used for hair removal and fat reduction machine.

• Brand Name: ECO MED PHARMACEUTICAL ULTRA SOUND GEL
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): ECO-MED PHARMACEUTICALS, INC.
• MDR Report Key: 12506214
• MDR Text Key: 272673126
• Report Number: MW5104079
• 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: 09/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 01/01/2014
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Weight: 77