FDA Adverse Event Injury Summary report: N

MEDICINAL LEECHES

MDR report key: 2983081 · Received February 26, 2013

Report

Report Number
MW5029170
Event Type
Injury
Date Received
February 26, 2013
Date of Event
February 9, 2013
Report Date
February 26, 2013
Manufacturer
LEECHES USA LTD
Product Code
NRN
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
TX, US
Reporter Occupation
NURSE

Narratives

Description of Event or Problem · 1

PURULENT DRAINAGE FROM WOUND POST MULTIPLE SURGERIES AND MEDICINAL LEECH TREATMENT FOR TRAUMATIC AMPUTATION OF THUMB WITH ATTEMPTED SURGICAL REIMPLANTATION. PT WAS ADMITTED ON (B)(6) 2013 FOR AMPUTATION OF LEFT THUMB WITH CIRCULAR SAW. REIMPLANTATION SURGERY WAS PERFORMED ON (B)(6) 2013. LEECH THERAPY WAS BEGUN IMMEDIATELY POST OP, AND WAS CONTINUED WITH LEECH CHANGES APPROXIMATELY EVERY 2 HOURS UNTIL (B)(6) 2013, WHEN THE SOFT TISSUE WAS DEBRIDED IN PREPARATION FOR FLAP RECONSTRUCTION. THE PT WAS ALSO COVERED WITH ANTIBIOTIC PROPHYLAXIS FROM ADMISSION FORWARD. THE PT UNDERWENT A TOTAL OF 6 SURGERIES, WITH THE LAST BEING ON (B)(6) 2013; A RECONSTRUCTIVE FLAP PLACEMENT TO LEFT THUMB. ON (B)(6) 2013, A SMALL AMOUNT OF PURULENT DRAINAGE WAS NOTED DURING ROUTINE EXAM, AND A CULTURE WAS SENT AND NEW ANTIBIOTICS AND WOUND CARE WERE STARTED. THE PT DID WELL AFTER THAT AND WAS DISCHARGED HOME ON (B)(6) 2013 WITH PO ANTIBIOTICS AND OUTPATIENT WOUND CARE. ON (B)(6) 2013, THE WOUND CULTURE WAS IDENTIFIED TO HAVE GROWN AEROMONAS HYDROPHILA, (B)(6), AND VIBRIO VULNIFICUS. THERE WAS A CONCERN THAT THE VIBRIO WAS ACQUIRED FROM THE LEECHES. ON (B)(6) 2013, INFECTION CONTROL REPORTED VIBRIO RESULT TO (B)(6) COUNTY HEALTH DEPARTMENT. (B)(6) THEN NOTIFIED (B)(6) DEPARTMENT OF STATE HEALTH SERVICES AND INVESTIGATION BEGAN. ON (B)(4) 2013, LEECHES USA LTD, SUPPLIER OF THE LEECHES, WAS CONTACTED TO FIND OUT IF THERE WERE OTHER REPORTS OF VIBRIO, AND NONE WERE REPORTED. ON (B)(6) 2013, CONFERENCE CALL HELD BETWEEN LOCAL AND STATE HEALTH DEPARTMENTS, HOSPITAL INFECTION CONTROL, AND (B)(6) FOR INSTRUCTIONS ON PROCESSING AND SENDING LEECHES AND WATER TO (B)(6) LAB.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
81021 MEDICINAL LEECHES NRN LEECHES USA LTD 112812 (PER SUPPLIER)

Patients

Seq Age Sex Outcome Treatment
1 50 YR Other