MAUDE Adverse Event Report: RICARIMPEX SAS LEECHES

Model Number BM

Device Problem Insufficient Information (3190)

Patient Problem Bacterial Infection (1735)

Event Date 03/08/2012

Event Type  No Answer Provided  

Event Description

The patient had a traumatic finger amputation and surgical reimplantation was attempted along with use of leech therapy.Erapenem was given as prophylaxis during this time.The reimplantation was not successful and the digits were subsequently removed via surgical amputation, soft tissue coverage was provided with a radial forearm flap and split thickness skin grafting.Subsequently the skin graft appeared infected.Cultures of the tissue were done and grew aeromonas resistant to ertapenem and fluoroquinolones.The patient required 3 surgical irrigation/debridement procedures, hyperbaric oxygen therapy and 19 days of iv antibiotics, including home infusion therapy.

Manufacturer Narrative

Due to the fact that leeches manufactured by ricarimpex had never been supplied to the healthcare facility that reported this event and that the leeches were not available for evaluation, it has not been possible to confirm that the leeches involved were ours.The alleged infectious agent, aeromonas hydrophila, is a bacteria that permanently inhabits the gut of the leech and is essential for the leech's digestive process.Infection by aeromonas is thus a well-known effect of leech therapy.Any infections are treatable with the appropriate antibiotics.The risk of an infection by aeromonas is amply discussed in our u.S.Labeling.

• Brand Name: LEECHES
• Type of Device: LEECHES
• Manufacturer (Section D): RICARIMPEX SAS; 245 avenue de saint medard; eysines 3332 0; FR 33320
• Manufacturer Contact: 245 avenue de saint medard; eysines 33320 ; 3355657841
• MDR Report Key: 4861411
• MDR Text Key: 21189427
• Report Number: 3009106257-2015-00002
• Device Sequence Number: 1
• Product Code: NRN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 06/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2012
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention