MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2013-04-01 for LEECHES manufactured by Ricarimpex.
[3162281]
Pt's left thumb was severed while using a circular saw. Pt was admitted to hosp for reimplantation surgery. An antibiotic prophylaxis was administered from admission forward and medicinal leech treatment was applied for traumatic amputation of thumb with attempted surgical reimplantation. Leech therapy was begun immediately post op, and was continued with leech changes approximately every 2 hrs. The pt underwent a total of 6 surgeries, developing a small amount of purulent drainage which was noted during routine exam. New antibiotics and wound care were started and a culture was sent. The pt did well after that and was discharged with po antibiotics and outpatient wound care. The wound culture performed by the hosp identified aeromonas hydrophilia and vibrio vulnificus. There was a concern that the vibrio was acquired from the leeches.
Patient Sequence No: 1, Text Type: D, B5
[10766370]
The confirmed infectious agent aeromonas hydrophila that was found in the wound culture performed by the health care facility is always found in the leeches' gut. Without it, the leech would die. This does not mean that the pt contracted aeromonas hydrophila from the leech, since these bacteria are present in water and in aerobic and anaerobic environments. However, risk of infection with aeromonas hydrophila is a well-known side effect of leech therapy and discussed at length in the leeches package insert, which also recommends prophylactic treatment with an antibiotic and a list of appropriate antibiotics. Ampicillin/sulbac (iv), the antibiotic administered by the hosp to the pt involved in this event, was not appropriate for prophylaxis; the package insert identified it as an "agent displaying in vitro or in vivo activity against this organism, but not used clinically for specific infections caused by this pathogen. " a total number of 160 leeches from two different lots were supplied separately to the health care facility, but then mixed in the storage tanks despite clear instructions to keep them separate. This make it impossible to determine from which lot the leeches used for treatment came from. Each of these lots originally consisted of 5,000 leeches. No other adverse event reported have been received. This strongly leads us to suspect that this pt's infection was not caused by the leeches, but by some other source, perhaps directly related to the nature and location of the accident. A search of published literature did not reveal any known association of vibrio vulnificus infections with leeches; the most common source of v vulnificus wound infections is exposure to salt or brackish water or handling of seafood.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2419564-2013-00001 |
| MDR Report Key | 3106768 |
| Report Source | 00 |
| Date Received | 2013-04-01 |
| Date of Report | 2013-02-06 |
| Date of Event | 2013-02-09 |
| Date Mfgr Received | 2013-02-26 |
| Date Added to Maude | 2013-05-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 300 SHAMES DR. |
| Manufacturer City | WESTBURY NY 11590 |
| Manufacturer Country | US |
| Manufacturer Postal | 11590 |
| Manufacturer Phone | 5163332570 |
| Manufacturer G1 | RICARIMPEX |
| Manufacturer Street | 245 AVE DE ST MEDARD |
| Manufacturer City | EYSINES 33320 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 33320 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEECHES |
| Generic Name | LEECHES |
| Product Code | NRN |
| Date Received | 2013-04-01 |
| Lot Number | 112812 OR 121912 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RICARIMPEX |
| Manufacturer Address | EYSINES FR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-04-01 |