MEDICINAL LEECHES

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-02-26 for MEDICINAL LEECHES manufactured by Leeches Usa Ltd.

Event Text Entries

[20229067] Purulent drainage from wound post multiple surgeries and medicinal leech treatment for traumatic amputation of thumb with attempted surgical reimplantation. Pt was admitted on (b)(6) 2013 for amputation of left thumb with circular saw. Reimplantation surgery was performed on (b)(6) 2013. Leech therapy was begun immediately post op, and was continued with leech changes approximately every 2 hours until (b)(6) 2013, when the soft tissue was debrided in preparation for flap reconstruction. The pt was also covered with antibiotic prophylaxis from admission forward. The pt underwent a total of 6 surgeries, with the last being on (b)(6) 2013; a reconstructive flap placement to left thumb. On (b)(6) 2013, a small amount of purulent drainage was noted during routine exam, and a culture was sent and new antibiotics and wound care were started. The pt did well after that and was discharged home on (b)(6) 2013 with po antibiotics and outpatient wound care. On (b)(6) 2013, the wound culture was identified to have grown aeromonas hydrophila, (b)(6), and vibrio vulnificus. There was a concern that the vibrio was acquired from the leeches. On (b)(6) 2013, infection control reported vibrio result to (b)(6) county health department. (b)(6) then notified (b)(6) department of state health services and investigation began. On (b)(4) 2013, leeches usa ltd, supplier of the leeches, was contacted to find out if there were other reports of vibrio, and none were reported. On (b)(6) 2013, conference call held between local and state health departments, hospital infection control, and (b)(6) for instructions on processing and sending leeches and water to (b)(6) lab.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5029170
MDR Report Key2983081
Date Received2013-02-26
Date of Report2013-02-26
Date of Event2013-02-09
Date Added to Maude2013-02-28
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Generic NameMEDICINAL LEECHES
Product CodeNRN
Date Received2013-02-26
Lot Number112812 (PER SUPPLIER)
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Sequence No1
Device Event Key0
ManufacturerLEECHES USA LTD
Manufacturer AddressWESTBURY NY US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2013-02-26

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