MAUDE Adverse Event Report: RICARIMPEX LEECHES; LEECHES HIRUDO MEDICINALIS

Model Number BM

Device Problem Insufficient Information (3190)

Patient Problems Bacterial Infection (1735); Post Operative Wound Infection (2446)

Event Date 05/15/2016

Event Type  Injury  

Manufacturer Narrative

The microbiological test performed by the healthcare facility on the leeches used on the patient established presence of the bacteria aeromonas.The leech has a symbiotic relationship with the aeromonas bacteria, which is always present in the digestive tract and on tegument of leeches.Thus, infection due to aeromonas is a well-known effect of leech therapy requiring prophylactic administration of antibiotics.The risk of an infection by aeromonas and required precautionary measures are amply discussed in our labeling.However, in this case, it has not been possible to establish when antibiotic treatment was administered--prior to leech therapy, at the start of leech therapy, or after the infection was detected.The issue is being investigated by the healthcare facility.The leeches were subject to routine microbiological testing prior to release for commercial distribution and were found to conform to specifications.No other reports of aeromonas infection have been received for the leech batch involved in this event.It has not been possible to establish the cause of the infection, since no additional testing for infectious agents was conducted by the healthcare facility neither on the leeches nor the infected flap.In accordance with verbal statement by second healthcare facility contact person (nurse), the infection was not due to nor caused by the leeches.Due to destruction of all leeches in stock at healthcare facility and patient treated and discharged prior to first contact with our distributor, no additional investigation is possible.

Event Description

Per initial information from healthcare facility, a patient had flap surgery and leeches were applied to the flap.The patient developed an infection and was treated with ciprofloxacine.The infection cleared up and the patient was discharged, no harm done.

• Brand Name: LEECHES
• Type of Device: LEECHES HIRUDO MEDICINALIS
• Manufacturer (Section D): RICARIMPEX; 245 avenue de saint medard; eysines, aquitaine 33320 ; FR 33320
• Manufacturer (Section G): RICARIMPEX; 245 avenue de saint medard; eysines, aquitaine 33320 ; FR 33320
• Manufacturer Contact: sonia barbe ; 245, avenue de saint medard; eysines, aquitaine 33320 ; FR 33320 ; 56578412
• MDR Report Key: 5779548
• MDR Text Key: 49082823
• Report Number: 3009106257-2016-00002
• Device Sequence Number: 1
• Product Code: NRN
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K040187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BM
• Device Lot Number: 16/266/B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention