BEUDAMED
    FDA Adverse Event Summary report: N

    LEECHES

    MDR report key: 4861366 · Received June 18, 2015

    Report

    Report Number
    3009106257-2015-00003
    Date Received
    June 18, 2015
    Date of Event
    February 9, 2013
    Report Date
    June 18, 2015
    Manufacturer
    RICARIMPEX SAS
    Product Code
    NRN
    PMA / PMN Number
    K040187
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR INVESTIGATION AND TESTING. HOWEVER, AN ISOLATE FROM THE PATIENT (WOUND CULTURE) AND 4 ISOLATES FROM THE ACTUAL DEVICE WERE SUBJECT TO TESTING BY AN INDEPENDENT THIRD PARTY AND THE RESULTS WERE EVALUATED BY THE MANUFACTURER, FINAL TEST RESULTS OF (B)(4) 2013 IDENTIFIED ONLY AEROMONAS IN ALL OF THE ISOLATES. VIBRIO VULNIFICUS WAS NOT DETECTED. THIS RESULT IS IN KEEPING WITH THE FACT THAT VIBRIO VULNIFICUS IS A BACTERIA THAT LIVES IN MARINE, I.E., SALTWATER ENVIRONMENTS, WHEREAS THE MEDICINAL LEECH HIRUDO MEDICINALIS LIVES ONLY IN A FRESHWATER ENVIRONMENT. THUS, CONTAMINATION OF THE LEECH BY VIBRIO VULNIFICUS IS NOT POSSIBLE DURING MANUFACTURING OR STORAGE. RICARIMPEX HAS EVALUATED THE MANUFACTURING RECORDS (DHR) OF THE TWO LOTS OF LEECHES THAT WERE SUPPLIED TO THE HEALTHCARE PROVIDER. (IDENTIFICATION OF THE SPECIFIC LOT INVOLVED IS NOT POSSIBLE DUE TO LOT MIX-UP DURING STORAGE AT THE HEALTH CARE FACILITY, CONTRARY TO INSTRUCTIONS PROVIDED BY THE MANUFACTURER,) THE DHR'S CONFORM TO SPECIFICATIONS. A REVIEW OF COMPLAINT RECORDS ESTABLISHED THAT NO REPORTS OF BACTERIAL INFECTION WERE RECEIVED FOR LOT NUMBER 12/2909/R4 NOR FOR LOT NUMBER 12/2411/R5. DUE TO ALL OF THE ABOVE, IT MAY BE THAT THE INFECTION WAS DUE TO AEROMONAS. AEROMONAS INFECTION IS A WELL KNOWN EFFECT OF LEECH THERAPY. HOSPITALS CANNOT IGNORE THE PRESENCE OF AEROMONAS IN THE DIGESTIVE TRACT AND ON TEGUMENT OF LEECHES, WHICH MAINTAIN A SYMBIOTIC RELATIONSHIP WITH AEROMONAS. ANY INFECTIONS ARE TREATABLE WITH THE APPROPRIATE ANTIBIOTICS. THE RISK OF AN INFECTION BY AEROMONAS IS AMPLY DISCUSSED IN OUR U.S. LABELING.

    Description of Event or Problem · 1

    THE PATIENT'S LEFT THUMB WAS SEVERED WHILE USING A CIRCULAR SAW AND THE PATIENT WAS SUBJECTED TO REIMPLANTATION SURGERY. AN ANTIBIOTIC PROPHYLAXIS WAS ADMINISTERED FROM ADMISSION AND MEDICINAL LEECH TREATMENT WAS APPLIED FOR TRAUMATIC AMPUTATION OF THUMB WITH ATTEMPTED SURGICAL REIMPLANTATION. LEECH THERAPY WAS BEGUN IMMEDIATELY POST-OP, WITH LEECH CHANGES APPROXIMATELY EVERY 2 HOURS, THE PATIENT UNDERWENT A TOTAL OF 6 SURGERIES, DEVELOPING A SMALL AMOUNT OF PURULENT DRAINAGE THAT WAS NOTED DURING ROUTINE EXAMINATION. NEW ANTIBIOTICS AND WOUND CARE WERE STARTED AND A CULTURE WAS SENT FOR ANALYSIS. THE PATIENT DID WELL AFTER THAT AND WAS DISCHARGED WITH PO ANTIBIOTICS AND OUTPATIENT WOUND CARE. THE WOUND CULTURE PERFORMED BY THE HOSPITAL IDENTIFIED AEROMONAS HYDROPHILIA AND VIBRIO VULNIFICUS. THERE WAS A CONCERN THAT THE VIBRIO V. WAS ACQUIRED FROM THE LEECHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398632 LEECHES LEECHES NRN RICARIMPEX SAS BM 12/2909R4, 12/2411R5

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention