BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FACHITA

    MDR report key: 372154 · Received January 18, 2002

    Report

    Report Number
    MW1023856
    Event Type
    Injury
    Date Received
    January 18, 2002
    Date of Event
    October 25, 2001
    Report Date
    January 18, 2002
    Manufacturer
    ALLOSOURCE
    Product Code
    LMO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON EVENT DATE, PT HAD PARTIAL HYSTERECTOMY AND A BLADDER SLING DONE VAGINALLY. TWO WEEKS LATER PT WAS VERY ILL WITH HIGH FEVER AND WITH POSSIBLE SEPTIC SHOCK. WENT TO EMERGENCY ROOM AND WAS DIAGNOSED WITH TWO ABSCESSES, ADMITTED INTO HOSP. PUT ON IV ANTIBIOTICS. SURGERY DONE NEXT DAY TO CLEAN ABSCESSES. DURING AND PRIOR TO SURGERY HAD A FOUL SMELL VAGINALLY AND BROWN DISCHARGE. WENT ALONG FOR ANOTHER TWO WEEKS ON ANTIBIOTICS ALONG WITH CONTINUED DISCHARGE AND FOUL SMELL. HAD ANOTHER SURGERY OF BLADDER (SCOPE SURGERY) AND PLACED ON ANTIBIOTICS WITH CONTINUING FOUL SMELL AND DISCHARGE, COULD HARDLY URINATE, STARTING FROM FIRST SURGERY COULDN'T URINATE. PT HAD SURGERY TO REMOVE BLADDER SLING, WHICH WAS NECROTIC AND IN PIECES. MD COULD NOT FIGURE OUT WHAT WAS WRONG. HE TOOK CULTURES OF OTHER BLADDER SLING THAT HE DID NOT USE AND THEY CAME BACK POSITIVE FOR SOME BACTERIA THAT THEY FOUND IN PT'S BODY. SUPPOSEDLY FDA WAS NOTIFIED AROUND THIS TIME AS WELL AS CENTER FOR DISEASE CONTROL (CDC INFORMED MD THAT THERE WAS ONLY TWO ANTIBIOTICS TO KILL THIS BACTERIA. PT PLACED ON ONE (1500 MG OF AMOXICILLIN FOR 11 DAYS). WENT BACK TO DR FOR URINALYSIS 3 DAYS AFTER FINISHING ANTIBIOTIC AND STILL TESTED POSITIVE FOR THE BACTERIA. PLACED ON THE SAME ANTIBIOTIC FOR ANOTHER 14 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FACHITA BLADDER SLING LMO ALLOSOURCE * *

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| R