BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CANNULA

    MDR report key: 4114292 · Received September 17, 2014

    Report

    Report Number
    MW5038276
    Event Type
    Injury
    Date Received
    September 17, 2014
    Date of Event
    August 6, 2014
    Report Date
    September 17, 2014
    Product Code
    MUU
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD INNER THIGH LIPOSUCTION AT (B)(6) ON (B)(6) 2014, AROUND 11:30AM. AFTER RETURNING HOME, I FOLLOWED POST OPERATIVE INSTRUCTIONS, TOOK MEDICATIONS AS DIRECTED AND WENT TO BED STILL WEARING THE COMPRESSING GARMENT THEY DRESSED ME IN AFTER SURGERY. I WOKE AT 2:00AM ((B)(6) 2014), WITH EXCRUCIATING PAIN IN MY RIGHT LOWER INNER THIGH ONLY, NEAR MY KNEE. I TOOK PAIN KILLERS IN HOPES IT WOULD SUBSIDE. THE PAIN CONTINUED TO INCREASE IN INTENSITY. SO, I HAD MY DAUGHTER CALL 911 AROUND 5:00 AM. I WAS TRANSPORTED TO (B)(6)'S EMERGENCY ROOM. I WAS THEN MOVED TO ICU. I WAS LATER DIAGNOSED WITH A BACTERIA CALLED CLOSTRIDIUM SEPTICUM. I WAS TRANSFERRED AGAIN TO ANOTHER HOSPITAL ICU (B)(6) FOR BETTER CARE. I SPENT A TOTAL OF 5 DAYS IN ICU, FIRST ON BROAD RANGE ANTIBIOTICS. THEN AFTER DIAGNOSED, I WAS GIVEN SPECIFIC ANTIBIOTICS BY IV DURING MY STAY. AFTER BEING DISCHARGED, I WAS ON ORAL ANTIBIOTICS FOR 5 WEEKS, UNTIL BEING RECENTLY CLEARED TO STOP TAKING THEM. I HAVE BEEN MEDICALLY CLEARED AND ASSURED I HAVE NO CANCEROUS MALIGNANCY THAT WOULD HAVE BEEN CAUSE FOR THIS BACTERIAL OUTBREAK. IT'S BEEN STATED TO ME AND IN MY MEDICAL RECORDS BY THE INFECTIOUS DISEASE DOCTOR AT (B)(6) WHOM TREATED ME (AT (B)(6)) THAT THE ONLY LOGICAL ANSWER TO HOW I WAS INFECTED BY THIS BACTERIA, IS THAT IT WAS INJECTED INTO ME AT THE TIME OF THE MEDICAL PROCEDURE AT (B)(6). I DO NOT KNOW IF IT WAS CONTAMINATED FLUIDS FROM A PHARMACEUTICAL PRODUCT, OR CONTAMINATED MEDICAL TOOLS. I DO KNOW IT NEEDS TO BE INVESTIGATED AGGRESSIVELY. I HAVE BEEN TOLD THIS IS A RARE CIRCUMSTANCE AND CLOSTRIDIUM SEPTICUM DOES NOT COMMONLY PRESENT IN THIS MANNER. FORTUNATELY, DUE TO MY EXCELLENT HEALTH I BEAT THE ODDS. I WAS CRITICAL, WAS BECOMING SEPTIC, HAD A MYOCARDIAL INFARCTION IN THE EMERGENCY ROOM, AND BARELY AVOIDED SURGERY TO REMOVE DEAD TISSUE. I AM SCARRED, MAY NOT OBTAIN FULL RANGE OF MOTION IN MY KNEE, AND HAVE SUFFERED GREATLY DURING THE ORDEAL. PLEASE TAKE MY COMPLAINT SERIOUSLY. I WAS TOLD MY CASE WAS REPORTED BY THE INFECTIONS DISEASE DOCTOR AT (B)(6) NEAR LEGACY (B)(6). REGARDS, (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575795 CANNULA CANNULA MUU

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| L