BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RED MEDICAL SUPPLIES MEDIUM VISCOSITY ULTRASOUND GEL

    MDR report key: 12546713 · Received September 28, 2021

    Report

    Report Number
    MW5104247
    Event Type
    Injury
    Date Received
    September 28, 2021
    Date of Event
    April 7, 2021
    Report Date
    September 25, 2021
    Product Code
    ITX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1442105 RED MEDICAL SUPPLIES MEDIUM VISCOSITY ULTRASOUND GEL TRANSDUCER, ULTRASONIC, DIAGNOSTIC ITX C004

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Other