MAUDE Adverse Event Report: CAROLINA BIOLOGICAL SUPPLY CO. MEDICINAL LEECH; EUROPEAN MEDICINAL LEECH, HIRUDO VERBANA

Device Problem Insufficient Information (3190)

Patient Problem Post Operative Wound Infection (2446)

Event Date 11/06/2015

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

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.

• Brand Name: MEDICINAL LEECH
• Type of Device: EUROPEAN MEDICINAL LEECH, HIRUDO VERBANA
• Manufacturer (Section D): CAROLINA BIOLOGICAL SUPPLY CO.; 2700 york rd.; burlington NC 27215
• Manufacturer (Section G): CAROLINA BIOLOGICAL SUPPLY CO.; 2700 york rd.; burlington NC 27215
• Manufacturer Contact: keith barker ; 2700 york rd.; burlington, NC 27215 ; 3363586377
• MDR Report Key: 5376476
• MDR Text Key: 36394087
• Report Number: 1048439-2016-00001
• Device Sequence Number: 1
• Product Code: NRN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140907
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No Information
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention