MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-26 for BIOPHARM LEECHES manufactured by Biopharm Leeches.
[30694363]
Pt initially hospitalized (b)(6) 2015 for motorcycle accident which resulted in subarachnoid hemorrhage, t7 fracture and open tibia/fibula fracture with flap. Pt received multiple surgeries to right lower extremity. Flap became congested and lost doppler signal with weakening of arterial signal, so pt received emergent venous reanastamosis. On (b)(6) 2015 pt started leach therapy for venous congestion in flap and began empiric levaquin. Pt become febrile, blood culture was drawn on (b)(6) 2015 revealing aeromonas infection resistant to ciprofloxacin, bactrim, and augmentin; only susceptible to ceftriaxone. Levaquin was stopped and ceftriaxone started.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5057729 |
| MDR Report Key | 5207839 |
| Date Received | 2015-10-26 |
| Date of Report | 2015-10-26 |
| Date Added to Maude | 2015-11-06 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 0 |
| Brand Name | BIOPHARM LEECHES |
| Generic Name | MEDICINAL LEECHES |
| Product Code | NRN |
| Date Received | 2015-10-26 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOPHARM LEECHES |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2015-10-26 |