• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ECO-MED PHARMACEUTICALS, INC. ECO MED PHARMACEUTICAL ULTRA SOUND GEL TRANSDUCER, ULTRASONIC, DIAGNOSTIC Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameECO MED PHARMACEUTICAL ULTRA SOUND GEL
Type of DeviceTRANSDUCER, ULTRASONIC, DIAGNOSTIC
Manufacturer (Section D)
ECO-MED PHARMACEUTICALS, INC.
MDR Report Key12506214
MDR Text Key272673126
Report NumberMW5104079
Device Sequence Number1
Product Code ITX
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Type of Report Initial
Report Date 09/16/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/01/2014
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

-
-