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.
[103671897]
The device is not available. The lot number is not available. Leeches proceeding from six different lots were distributed to (b)(4) in 2017. Leeches from these same lots were also distributed in the united states. No other adverse reactions nor events have been reported from either country during this time period. Manufacturing records and acceptance testing results for all these lots have been checked by the manufacturer and found conforming to specifications upon release. The manufacturer's investigation is ongoing. 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
[103671898]
On (b)(6) 2017 - after suffering an injury with a circle saw to thumb, a flap / re-implantation was performed on patient. On (b)(6) 2017 - leech therapy commenced and patient started on trimethoprim-sulfamethoxazole for prophylaxis. On (b)(6) 2017 - flap failure. Patient returned to or for incision and drainage; evidence of infection. On (b)(6) 2017 - patient switched to ciprofloxacin. On (b)(6) 2017 - patient started on ertapenem on (b)(6) 2017 - patient returned to operating room for more debridement and finally revision amputation and removal of sequestra. On (b)(6) 2017 - ertapenem completed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2419564-2018-00001 |
| MDR Report Key | 7376933 |
| Date Received | 2018-03-28 |
| Date of Report | 2018-06-06 |
| Date of Event | 2017-11-01 |
| 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 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 |