FDA Adverse Event
Summary report: N
LEECHES
MDR report key: 11470
·
Received February 7, 1994
Report
- Report Number
- MW4000273
- Date Received
- February 7, 1994
- Date of Event
- September 24, 1992
- Report Date
- October 8, 1992
- Manufacturer
- LEECHES USA LTD
- Report Source
- Voluntary report
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
ON 9/24/92, LEECH TREATMENT WAS INITIATED ON A PT FOLLOWING RADICAL CANCER SURGERY WHICH INVOLVED REMOVAL AND REPLACEMENT OF THE RIGHT EAR. THE PT DEVELOPED SEPSIS, WHICH IS FELT COULD HAVE BEEN CAUSED BY THE WATER THE LEECHES WERE STORED IN SINCE THE SEPSIS COULD NOT BE ATTRIBUTED TO ANY OTHER SOURCE. CULTURED FROM THE WATER WAS AEROMONAS HYDROPHILA, WHICH IS NORMAL FLORA FOR LEECHES. ALSO CULTURED WERE MARINE ORGANISMS, CHROMOBACTER VIOLACEUM AND VIBRIO ALGINOLYTICUS WHICH ARE NOT ASSOCIATED WITH LEECHES AND ARE UNUSUAL ORGANISMS FOR THE AREA. THE PT'S BLOOD CULTURE WAS NEGATIVE WHICH THE PHYSICIAN FEELS WAS DUE TO THE FACT THAT HE WAS ON INNUMERABLE ANTIBIOTICS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LEECHES | LEECHES USA LTD | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |