MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-02-06 for LEECHES BM manufactured by Ricarimpex.
[20459550]
Woman, (b)(6) years old, was hospitalized on (b)(6) 2012 for skin graft on a wound of skull. The pt has received a treatment with leeches because of outstanding skin graft. The use of 8 leeches on (b)(6) 2012 and 10 on (b)(6) 2012 (number of batch 12/100/b). On (b)(6) 2012, she shows the following unwanted effect: infection with aeromonas localized on the wound. Clinical signs are: graft necrosis, fever, inflammatory peri-orbital infiltration. The wound was malodorous when treated. Improvement of the state of the pt on (b)(6) 2012 with the following treatment: gentamycin 150mg/day from 19 to (b)(6) 2012 and clarofan 2g 3times/day began on (b)(6) 2012. Pt condition developed favorably. Pt discharged and well.
Patient Sequence No: 1, Text Type: D, B5
[20564224]
The hosp reported the event to ricarimpex on (b)(6) 2012 and to ansm ((b)(4) regulatory agency) on (b)(4) 2012. Ricarimpex reviewed records and established that there had been no other reports aeromonas hydrophila bacterial infection for batch 12/100/b. Infection due to aeromonas is a well-known effect of leech therapy. Hospitals cannot ignore the presence of aeromonas in digestive tract and on tegument of leeches, symbiotic relationship. Any infections are treatable with the appropriate antibiotics. The risk of an infection by aeromonas is amply discussed in our us labeling.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3009106257-2015-00001 |
| MDR Report Key | 4502481 |
| Report Source | 05 |
| Date Received | 2015-02-06 |
| Date of Report | 2015-02-05 |
| Date of Event | 2015-04-16 |
| Date Mfgr Received | 2012-05-31 |
| Device Manufacturer Date | 2012-01-02 |
| Date Added to Maude | 2015-03-11 |
| 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 | 56578412 |
| 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 | 2015-02-06 |
| Model Number | BM |
| Lot Number | 12/100/B |
| 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 | 245 AVENUE DE SAINT MEDARD EYSINES 33320 FR 33320 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-02-06 |