BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDIUM VISCOSITY ULTRASOUND GEL

    MDR report key: 12474826 · Received September 14, 2021

    Report

    Report Number
    MW5103922
    Event Type
    Injury
    Date Received
    September 14, 2021
    Date of Event
    April 1, 2021
    Product Code
    ITX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD A CAVITY FILLED, TOOK ANTIBIOTICS BUT WENT SEPTIC WITHIN DAYS. NO ONE COULD FIGURE OUT WHY IT WAS SO BAD AND HAPPENED SO QUICKLY. I WAS PREGNANT AND ENDED UP NEEDING 2000MG OF CLINDAMYCIN A DAY TO FIGHT THE INFECTION. AND TOOTH PAIN BLOCKER AT THE EMERGENCY ROOM. THEN A FEW MONTHS LATER I DELIVERED A COUPLE WEEKS EARLY BECAUSE OF A PARTIAL PLACENTA ABRUPTION WHICH AGAIN NO ONE HAD S GOOD REASON AS TO WHAT HAPPENED. I HAVE HAD 6 PREVIOUS CHILDREN AND MY KIDS ALWAYS COME LATE SO THIS WAS COMPLETELY UNEXPECTED AND OUT OF MY NORM. NOW I'M WONDERING IF THE ULTRASOUND GEL THAT WAS RECALLED, WHICH I USED A LOT WITH MY AT HOME FETAL DOPPLER, HAD ANYTHING TO DO WITH IT BECAUSE SEPSIS WAS APPARENTLY A PROBLEM. RED MEDICAL SUPPLIES. REASON FOR USE: ULTRASOUND GEL. ON THE BELLY WITH A FETAL DOPPLER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1368940 MEDIUM VISCOSITY ULTRASOUND GEL TRANSDUCER, ULTRASONIC, DIAGNOSTIC ITX C014

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other| R