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

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.

• Brand Name: RED MEDICAL SUPPLIES, MEDIUM VELOCITY ULTRASOUND GEL MULTI PURPOSE,
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): ECO-MED PHARMACEUTICALS, INC.
• MDR Report Key: 12481457
• MDR Text Key: 272484524
• Report Number: MW5104007
• 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: 09/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 02/15/2024
• 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; Disability
• Patient Age: 56 YR
• Patient Weight: 52