BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDICINAL LEECH

    MDR report key: 5376476 · Received January 14, 2016

    Report

    Report Number
    1048439-2016-00001
    Event Type
    Injury
    Date Received
    January 14, 2016
    Date of Event
    November 6, 2015
    Report Date
    January 14, 2016
    Manufacturer
    CAROLINA BIOLOGICAL SUPPLY CO.
    Product Code
    NRN
    PMA / PMN Number
    K140907
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    0

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE WE HAVE BEEN UNABLE TO CONFIRM ANY DETAILS OF THIS REPORTED EVENT, INCLUDING WHETHER THE LEECHES INVOLVED WERE SUPPLIED BY CAROLINA BIOLOGICAL SUPPLY, THE NATURE OF THE INJURIES ALLEGED, AND TREATMENT. ATTEMPTS TO OBTAIN ADD'L INFO FROM THE HEALTH CARE FACILITY RESPONSIBLE FOR THE VOLUNTARY EVENT ARE ONGOING. ANY APPROPRIATE INFO OBTAINED WILL BE COMMUNICATED TO FDA IN A F/U REPORT. AEROMONAS HYDROPHILA INFECTIONS ARE A WELL-KNOWN RISK ASSOCIATED WITH LEECH TREATMENT, THUS THE DETAILS CONVEYED IN THE VOLUNTARY EVENT REPORT DO NOT SUGGEST AN UNANTICIPATED ADVERSE EVENT. A. HYDROPHILA IS AN ENDOSYMBIOTIC BACTERIUM THAT IS A NORMAL PART OF THE LEECH GUT FLORA, AND MEDICAL PRACTITIONERS OFTEN PLACE THEIR PTS ON ANTIBIOTICS PRIOR TO STARTING LEECH THERAPY AS A PRECAUTIONARY MEASURE. IT IS ALSO KNOWN THAT SOME HOSPITALS MAY RECEIVE LEECHES THAT CONTAIN ANTIBIOTIC RESISTANT A. HYDROPHILA. THE VOLUNTARY EVENT REPORT ALLEGES INITIAL PROPHYLACTIC ADMINISTRATION OF LEVAQUIN, WHICH IS NOT ONE OF THE ANTIBIOTICS RECOMMENDED IN THE PRODUCT INSTRUCTIONS.

    Description of Event or Problem · 1

    PER MEDWATCH REPORT MW5057729, A PT WAS TREATED WITH MEDICINAL LEECHES WITH CONCURRENT PROPHYLACTIC ADMINISTRATION OF LEVAQUIN AND SUBSEQUENTLY BECAME FEBRILE. BLOOD CULTURE REVEALED AEROMONAS INFECTION RESISTANT TO CIPROFLOXACIN, BACTRIM, AND AUGMENTIN, BUT SUSCEPTIBLE TO CEFTRIAXONE. LEVAQUIN WAS STOPPED AND CEFTRIAXONE STARTED. ATTEMPTS TO OBTAIN ADD'L INFO FROM THE HEALTH CARE FACILITY RESPONSIBLE FOR THE VOLUNTARY EVENT REPORT ARE ONGOING. ANY APPROPRIATE INFO OBTAINED WILL BE COMMUNICATED TO FDA IN A F/U REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25707 MEDICINAL LEECH EUROPEAN MEDICINAL LEECH, HIRUDO VERBANA NRN CAROLINA BIOLOGICAL SUPPLY CO. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention