LEECHES USA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-06-04 for LEECHES USA manufactured by Leeches Usa.

Event Text Entries

[2741673] Pt suffered a traumatic amputation of his left index finger and middle finger on (b)(6). He was transported to (b)(6) hospital where he underwent reimplantation of the index finger to the long finger and subsequently with subsequent grafts. He was given cefazolin prophylaxis and subsequent ciprofloxacin prophylaxis due to use of leech therapy. Leeches were used at the nailbed area of the reimplantation from (b)(6). He was dismissed from the hospital on (b)(6). He called on (b)(6) saying that an abrasion which he developed on the tip of his thumb on that side also had developed some drainage and was given ciprofloxacin 500 mg for this. (b)(6), he went to the emergency room as he had drainage from the log finger amputation site. He said it smelled bad. He was seen in the emergency room in (b)(6) hospital. Cultures of the wound infection of the amputation site from (b)(6) hospital on (b)(6) grew aeromonas hydrophilia. The organism was quinolone (ciprofloxacin and levofloxacin) intermediate and sulfamethoxazole / trimethoprim resistant. Subsequent cultures on (b)(6) at (b)(6) grew proteus vulgaris (ciprofloxacin and sulfamethoxazole resistant) and (b)(6). Pt require hospitalization, and required 2 weeks of antibiotics (ceftriaxone iv and metronidazole po) which were continued as an outpatient. This is ongoing at date of this report on (b)(6) 2012. Dose: q4h, topical.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5025693
MDR Report Key2604924
Date Received2012-06-04
Date of Report2012-06-04
Date of Event2012-05-22
Date Added to Maude2012-06-11
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPHARMACIST
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameLEECHES USA
Generic NameMEDICINAL LEECHES
Product CodeNRN
Date Received2012-06-04
Lot NumberNO LOT #S FOUND
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Sequence No1
Device Event Key0
ManufacturerLEECHES USA
Manufacturer Address300 SHAMES DR. WESTBURY NY 11590 US 11590


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2012-06-04

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