MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-28 for LEECHES BM manufactured by Ricarimpex.
[103676751]
As per the manufacturer's investigation, manufacturing records including acceptance testing results were checked and found to be conforming to specifications upon release. The device is not available. The early failure of the implant indicates a vascularization problem rather than an infection problem due to the leech. The limited test results available are contradictory and not conclusive. If additional information becomes available, a follow-up report will be submitted. The presence of symbiotic aeromonas and other bacterial species in the leech's digestive tract is essential for the animal's growth and survival. Prophylactic antibiotic treatment is always advisable.
Patient Sequence No: 1, Text Type: N, H10
[103676752]
On (b)(6) 2018 - after suffering an avulsion injury of thumb while repairing conveyer belt, the thumb was re-implanted and leech therapy commenced, with a single dose of piperacillin-tazobactam. Patient then started on ciprofloxacin and trimethoprim-sulfamethoxazole for prophylaxis. On (b)(6) 2018 - the patient suffers fever and the implanted digit looks like an early failure. On (b)(6) 2018 - prophylaxis changed to ertapenem. On (b)(6) 2018 - patient returned to or with revision amputation. Evidence of infection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2419564-2018-00002 |
| MDR Report Key | 7377080 |
| Date Received | 2018-03-28 |
| Date of Report | 2018-06-06 |
| Date of Event | 2018-01-30 |
| Date Facility Aware | 2018-05-07 |
| Report Date | 2018-06-06 |
| Date Reported to FDA | 2018-06-06 |
| Date Reported to Mfgr | 2018-03-28 |
| Date Added to Maude | 2018-03-28 |
| 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 | 2018-03-28 |
| Model Number | BM |
| Lot Number | 17/650/B |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 3 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; 2. Deathisabilit | 2018-03-28 |