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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ECO-MED PHARMACEUTICALS, INC. RED MEDICAL SUPPLIES, MEDIUM VELOCITY ULTRASOUND GEL MULTI PURPOSE, TRANSDUCER, ULTRASONIC, DIAGNOSTIC

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ECO-MED PHARMACEUTICALS, INC. RED MEDICAL SUPPLIES, MEDIUM VELOCITY ULTRASOUND GEL MULTI PURPOSE, TRANSDUCER, ULTRASONIC, DIAGNOSTIC Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Pain (1994); Rash (2033); Skin Tears (2516); Skin Inflammation/ Irritation (4545)
Event Date 07/03/2021
Event Type  Injury  
Event Description
After using eco med, red gel, i have had a sore on the side of face and a sore on my neck, breathing issues; inside my nose, is a sore and an excruciating, rash on my buttocks and genitalia. I was talking with my husband, trying to eliminate, all possibilities, nothing. Until, i saw the recall letter, from (b)(6) and think, this is what has caused this for months. The neck and head first, the slight breathing issue, and then, currently, the large genital rash witch i found a sore on the inside of my thigh. I've never had this issue beforehand. The clinics and hospitals, are backed up here due to 2, major hurricanes and covid which, i won't have a dr, appt, until (b)(6). About, these problems, i'm concerned, because it has spread or is spreading. I have used this product, as directed. I remove with tissues, and use only externally. However, i take baths, not showers. I believe, the residue of the gel contaminated the warm water and hence, the painful, rash on my body. That is my thoughts, on how it may spread. (b)(6), 2 major hurricanes, just hit and covid, has made it nearly, impossible to get a dr. Visit.
 
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Brand NameRED MEDICAL SUPPLIES, MEDIUM VELOCITY ULTRASOUND GEL MULTI PURPOSE,
Type of DeviceTRANSDUCER, ULTRASONIC, DIAGNOSTIC
Manufacturer (Section D)
ECO-MED PHARMACEUTICALS, INC.
MDR Report Key12481457
MDR Text Key272484524
Report NumberMW5104007
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 09/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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

Patient Treatment Data
Date Received: 09/15/2021 Patient Sequence Number: 1
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