MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2015-06-18 for LEECHES BM manufactured by Ricarimpex Sas.
[5860503]
The patient's left thumb was severed while using a circular saw and the patient was subjected to reimplantation surgery. An antibiotic prophylaxis was administered from admission and medicinal leech treatment was applied for traumatic amputation of thumb with attempted surgical reimplantation. Leech therapy was begun immediately post-op, with leech changes approximately every 2 hours, the patient underwent a total of 6 surgeries, developing a small amount of purulent drainage that was noted during routine examination. New antibiotics and wound care were started and a culture was sent for analysis. The patient did well after that and was discharged with po antibiotics and outpatient wound care. The wound culture performed by the hospital identified aeromonas hydrophilia and vibrio vulnificus. There was a concern that the vibrio v. Was acquired from the leeches.
Patient Sequence No: 1, Text Type: D, B5
[13467177]
The device was not returned for investigation and testing. However, an isolate from the patient (wound culture) and 4 isolates from the actual device were subject to testing by an independent third party and the results were evaluated by the manufacturer, final test results of (b)(4) 2013 identified only aeromonas in all of the isolates. Vibrio vulnificus was not detected. This result is in keeping with the fact that vibrio vulnificus is a bacteria that lives in marine, i. E. , saltwater environments, whereas the medicinal leech hirudo medicinalis lives only in a freshwater environment. Thus, contamination of the leech by vibrio vulnificus is not possible during manufacturing or storage. Ricarimpex has evaluated the manufacturing records (dhr) of the two lots of leeches that were supplied to the healthcare provider. (identification of the specific lot involved is not possible due to lot mix-up during storage at the health care facility, contrary to instructions provided by the manufacturer,) the dhr's conform to specifications. A review of complaint records established that no reports of bacterial infection were received for lot number 12/2909/r4 nor for lot number 12/2411/r5. Due to all of the above, it may be that the infection was due to aeromonas. Aeromonas infection is a well known effect of leech therapy. Hospitals cannot ignore the presence of aeromonas in the digestive tract and on tegument of leeches, which maintain a symbiotic relationship with aeromonas. Any infections are treatable with the appropriate antibiotics. The risk of an infection by aeromonas is amply discussed in our u. S. Labeling.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3009106257-2015-00003 |
| MDR Report Key | 4861366 |
| Report Source | 00 |
| Date Received | 2015-06-18 |
| Date of Report | 2015-06-18 |
| Date of Event | 2013-02-09 |
| Date Mfgr Received | 2013-02-26 |
| Device Manufacturer Date | 2012-11-01 |
| Date Added to Maude | 2015-06-24 |
| 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 | 245 AVENUE DE SAINT MEDARD |
| Manufacturer City | EYSINES 33320 |
| Manufacturer Country | FR |
| Manufacturer Postal | 33320 |
| Manufacturer Phone | 3355657841 |
| 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 | 2015-06-18 |
| Model Number | BM |
| Lot Number | 12/2909R4, 12/2411R5 |
| 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 SAS |
| Manufacturer Address | 245 AVENUE DE SAINT MEDARD EYSINES 33320 FR 33320 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-06-18 |