MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2016-01-14 for MEDICINAL LEECH NI manufactured by Carolina Biological Supply Co..
[36394087]
To date we have been unable to confirm any details of this reported event, including whether the leeches involved were supplied by carolina biological supply, the nature of the injuries alleged, and treatment. Attempts to obtain add'l info from the health care facility responsible for the voluntary event are ongoing. Any appropriate info obtained will be communicated to fda in a f/u report. Aeromonas hydrophila infections are a well-known risk associated with leech treatment, thus the details conveyed in the voluntary event report do not suggest an unanticipated adverse event. A. Hydrophila is an endosymbiotic bacterium that is a normal part of the leech gut flora, and medical practitioners often place their pts on antibiotics prior to starting leech therapy as a precautionary measure. It is also known that some hospitals may receive leeches that contain antibiotic resistant a. Hydrophila. The voluntary event report alleges initial prophylactic administration of levaquin, which is not one of the antibiotics recommended in the product instructions.
Patient Sequence No: 1, Text Type: N, H10
[36394088]
Per medwatch report mw5057729, a pt was treated with medicinal leeches with concurrent prophylactic administration of levaquin and subsequently became febrile. Blood culture revealed aeromonas infection resistant to ciprofloxacin, bactrim, and augmentin, but susceptible to ceftriaxone. Levaquin was stopped and ceftriaxone started. Attempts to obtain add'l info from the health care facility responsible for the voluntary event report are ongoing. Any appropriate info obtained will be communicated to fda in a f/u report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1048439-2016-00001 |
| MDR Report Key | 5376476 |
| Report Source | OTHER |
| Date Received | 2016-01-14 |
| Date of Report | 2016-01-14 |
| Date of Event | 2015-11-06 |
| Date Mfgr Received | 2015-12-15 |
| Date Added to Maude | 2016-01-19 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. KEITH BARKER |
| Manufacturer Street | 2700 YORK RD. |
| Manufacturer City | BURLINGTON NC 27215 |
| Manufacturer Country | US |
| Manufacturer Postal | 27215 |
| Manufacturer Phone | 3363586377 |
| Manufacturer G1 | CAROLINA BIOLOGICAL SUPPLY CO. |
| Manufacturer Street | 2700 YORK RD. |
| Manufacturer City | BURLINGTON NC 27215 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27215 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MEDICINAL LEECH |
| Generic Name | EUROPEAN MEDICINAL LEECH, HIRUDO VERBANA |
| Product Code | NRN |
| Date Received | 2016-01-14 |
| Model Number | NI |
| Catalog Number | NI |
| Lot Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | I |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAROLINA BIOLOGICAL SUPPLY CO. |
| Manufacturer Address | 2700 YORK RD. BURLINGTON NC 27215 US 27215 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-01-14 |