MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-08 for LEECHES BM manufactured by Ricarimpex.
[49125656]
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 device 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. It has also 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 contacting leeches usa, no additional investigation is possible. Per the manufacturer, the leeches were subject to routine microbiological testing prior to release for commercial distribution and were found to conform to specs. No other reports of aeromonas infection have been received for the leech batch involved in this event.
Patient Sequence No: 1, Text Type: N, H10
[49125657]
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 ciprofloxacin. The infection cleared up and the patient was discharged, no harm done. Per second healthcare facility contact person (nurse), the infection was not due to nor caused by the leeches.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2419564-2016-00001 |
| MDR Report Key | 5780465 |
| Date Received | 2016-07-08 |
| Date of Report | 2016-07-08 |
| Date of Event | 2016-05-15 |
| Date Facility Aware | 2016-06-08 |
| Report Date | 2016-07-08 |
| Date Reported to FDA | 2016-07-08 |
| Date Reported to Mfgr | 2016-07-07 |
| Date Added to Maude | 2016-07-08 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEECHES |
| Generic Name | LEECHES HIRUDO MEDICINALIS |
| Product Code | NRN |
| Date Received | 2016-07-08 |
| Model Number | BM |
| Lot Number | 16/266/B |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 2 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RICARIMPEX |
| Manufacturer Address | 245 AVENUE DE SAINT MEDARD EYSINES, AQUITAINE 33320 FR 33320 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-07-08 |