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

Lot Number C004

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abortion (1688); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/07/2021

Event Type  Injury  

Event Description

I am a breeder of danes and had bred two of my females.I used ultrasound gel to check puppies on my machines.Both females somehow miscarried or absorbed the puppies.One female is a proven dam so it was very strange to have both females miscarry.My stud dog is also a proven stud.The lot number from these gels were c004 red medical supplies manufactured by eco med.I also have used this gel on myself to check on thyroid nodules etc.I will admit i have not felt amazing since but am not sure if i need to have specific blood work done to make sure.I saved the bottles just in case you guys wanted to test them yourselves.

• Brand Name: RED MEDICAL SUPPLIES MEDIUM VISCOSITY ULTRASOUND GEL
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): ECO-MED PHARMACEUTICALS, INC
• MDR Report Key: 12546713
• MDR Text Key: 274004453
• Report Number: MW5104247
• 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: 09/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 02/15/2024
• Device Lot Number: C004
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 3 YR