MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,06 report with the FDA on 2015-06-18 for LEECHES BM manufactured by Ricarimpex Sas.
[21189427]
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.
Patient Sequence No: 1, Text Type: D, B5
[21444285]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3009106257-2015-00002 |
| MDR Report Key | 4861411 |
| Report Source | 00,06 |
| Date Received | 2015-06-18 |
| Date of Report | 2015-06-18 |
| Date of Event | 2012-03-08 |
| Date Mfgr Received | 2012-04-27 |
| Date Added to Maude | 2015-06-25 |
| 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 |
| Reporter Occupation | PHARMACIST |
| 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 | 0 |
| 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 |
| 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 |